NewRegulatory Affairs Manager Dentsply SironaRegulatory Affairs ManagerSan Diego, CAThis role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance. • Manages day-to-day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, and succession planning.
Associate Labeling Specialist - Regulatory Affairs Applied Medical Resources CorpAssociate Labeling Specialist - Regulatory AffairsRancho Santa Margarita, CA$71,000–$80,000 / yearThe Associate Labeling Specialist works cross-functionally to support labeling projects from design input through final approval, making this an ideal opportunity for professionals with a background in regulatory affairs, quality assurance, or technical writing in the medical device industry. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.
Associate Labeling Specialist – Regulatory Affairs Applied MedicalAssociate Labeling Specialist – Regulatory AffairsRancho Santa Margarita, California$71,000–$80,000 / yearThe Associate Labeling Specialist works cross-functionally to support labeling projects from design input through final approval, making this an ideal opportunity for professionals with a background in regulatory affairs, quality assurance, or technical writing in the medical device industry. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.
Sr. Specialist, Regulatory Affairs Metagenics LLCSr. Specialist, Regulatory AffairsAliso Viejo, CAIndustry Surveillance: Monitors competitive claims, FDA's and FTC''s actions, litigation, news releases and other sources, as they relate to the current science of Metagenics-related products and challenges to relevant product claims, to ensure that Metagenics limits its exposure for product claims both domestically and internationally. The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs.
Sr. Specialist, Regulatory Affairs MetagenicsSr. Specialist, Regulatory AffairsAliso Viejo, CaliforniaMonitors competitive claims, FDA’s and FTC's actions, litigation, news releases and other sources, as they relate to the current science of Metagenics-related products and challenges to relevant product claims, to ensure that Metagenics limits its exposure for product claims both domestically and internationally. The wage range for this role takes into account the wide range of factors that are considered in making compensation decisions including but not limited to skill sets; experience and training; licensure and certifications; and other business and organizational needs.
Director, Regulatory Affairs Mapp BiopharmaceuticalDirector, Regulatory AffairsSan Diego, CARemote$130,000–$250,000 / yearDirector, Regulatory Affairs FULLY REMOTE Assignment through Temporary Agency - Approximately 6 Months Approximately 40 Hours Per Week Job #26-01AT / #26-01A Mapp Biopharmaceutical, Inc. "Mapp" is a San Diego based, innovative biopharmaceutical company focused on addressing unmet medical needs through the development of life-saving monoclonal antibody treatment options to combat a variety of neglected and tropical infectious diseases, and in support of biodefense programs. The Early Research and Development Group (ERDG) and the Advanced Research and Development Group (ARDG) at Mapp Biopharmaceutical are responsible for the execution of high quality Research and Development activities to ensure the achievement of a robust portfolio through CMC, Nonclinical, Regulatory, Project Management, and Clinical activities consistent with Mapp's product development objectives.
Regulatory Affairs Specialist - Vascular (on-site) AbbottRegulatory Affairs Specialist - Vascular (on-site)Temecula, South CarolinaOur extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. The ideal candidate will possess strong analytical and project management skills, a working knowledge of medical device regulations, and the ability to interpret complex regulatory requirements and apply them to product development and lifecycle management activities.
Regulatory Affairs Specialist - Vascular (on-site) Abbott LaboratoriesRegulatory Affairs Specialist - Vascular (on-site)Temecula, CA$81,500–$141,300 / yearOur extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. The ideal candidate will possess strong analytical and project management skills, a working knowledge of medical device regulations, and the ability to interpret complex regulatory requirements and apply them to product development and lifecycle management activities.
Regulatory Affairs Specialist - Vista, CA Grifols SARegulatory Affairs Specialist - Vista, CAVista, CA$80,546–$120,819 / yearThis position will maintain appropriate documentation and files including but not limited to: Facility licensure, Error & Accident (Deviation) Reports, Deferred Donor List (DDL), Viral Marker Data Forms, Monthly Plasma Yields Spread Sheet, PPTA Epidemiology Data Spreadsheet, Doctor, Manager, and Physician Substitute Approval Letters, Final Disposition of Units, and Recalls. Performs review of Deviation Reports and associated documentation to ensure completeness, including documented evidence of impact assessments as a part of risk management and completion of all CAPA actions required by the report have occurred.
Regulatory Affairs Specialist Quidelortho CorpRegulatory Affairs SpecialistSan Diego, CAQuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. Regulatory Operations provides infrastructure to the broader department through the creation and continuous improvement of regulatory processes, implementation and maintenance of regulatory software systems, and management of centralized regulatory services and support functions.
Sr Specialist | Licensing & Accreditation | Regulatory Affairs | Sharp Memorial Hospital | FT Days Sharp Health PlanSr Specialist | Licensing & Accreditation | Regulatory Affairs | Sharp Memorial Hospital | FT DaysSan Diego, CA$53.57–$69.12 / hourThis role serves as a key multi‑hospital liaison between operational leaders and regulatory and accreditation agencies during survey preparation, response, and follow‑up, working in close alignment with the Director of Licensing and Accreditation, Multi‑Hospital, and the Manager of Licensing and Accreditation, Multi‑Hospital. The actual pay rate and pay grade for this position will be dependent on a variety of factors, including an applicant's years of experience, unique skills and abilities, education, alignment with similar internal candidates, marketplace factors, other requirements for the position, and employer business practices.
Director, Regulatory Affairs Strategy Travere Therapeutics IncDirector, Regulatory Affairs StrategySan Diego, CARemote$189,000–$246,000 / yearPosition Summary: The Director, Regulatory Affairs Strategy is responsible for developing and executing global regulatory strategies for Phase 2 and Phase 3 development programs to support successful clinical development, registration, and commercialization of investigational products. Compensation: Our competitive compensation package includes a combination of both cash compensation (base pay and short-term incentive) and long-term incentive compensation (company stock), designed to recognize, retain, and reward employees.
Director Regulatory Affairs - CMC Clinical Dynamix, Inc.Director Regulatory Affairs - CMCSan Diego, CAResponsible for the regulatory CMC leadership of one or more commercial and development projects, including responsibility for regulatory strategy, IND/CTA preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies with focus on the CMC aspects. Extensive project regulatory leadership and expertise, specifically focused on the CMC aspects for small molecules, biologics, and/or gene therapies.
Senior Regulatory Affairs Specialist - Manager Synaptic Medical LLCSenior Regulatory Affairs Specialist - ManagerCarlsbad, CAKey responsibilities: Lead the regulatory strategy for new product development and market entry, including 510(k), PMA, and CE Mark submissions. What we are looking for: Bachelor's degree in a scientific, engineering, or related field (RAC certification or advanced degree a plus).
Director, Regulatory Affairs (Labeling) Arrowhead PharmaceuticalsDirector, Regulatory Affairs (Labeling)San Diego, CA$210,000–$230,000 / yearManage development, review, approval, and version control of labeling documents, including Target Product Labeling, Core Labeling (e.g., Company Core Data Sheet [CCDS]), and Regional Labeling (e.g., USPI, EU SmPC), in a timely manner according to internal SOPs and external regulatory requirements. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Project Manager, Regulatory Affairs (Clinical and CMC) Mitchell MartinProject Manager, Regulatory Affairs (Clinical and CMC)Encinitas, CARemote$58.80–$84 / hourBy applying for this job, you agree to receive AI-generated calls, text messages, and/or emails from Mitchell Martin Inc and its affiliates and contracted partners at various frequency through traditional and automated methods. Join our team as a Project Manager in Regulatory Affairs, focusing on Clinical and CMC.
Regulatory Affairs Manager F. Hoffmann-La Roche LtdRegulatory Affairs ManagerCA$106,000–$197,000 / yearYou have 3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent. You understand the structure, key roles and responsibilities of external customers/stakeholders and communicate timely and effectively the needs of external customers/stakeholders.
Senior Director, Global Regulatory Affairs Janux TherapeuticsSenior Director, Global Regulatory AffairsSan Diego, CaliforniaThis role requires a hands-on regulatory leader with deep experience in early clinical development (Phase 1/2), coordinating multiple parallel regulatory initiatives, strong health authority interaction experience, the ability to exercise judgment with decisions that have long-term impact on regulatory function success, and guide teams through ambiguity and evolving data. This individual will lead global regulatory strategy for one or more programs while influencing and partnering closely with cross-functional stakeholders to shape development plans and ensuring alignment across functions in a dynamic, fast-paced environment.
Senior Regulatory Affairs Specialist – Vascular (on-site) AbbottSenior Regulatory Affairs Specialist – Vascular (on-site)Temecula, South CarolinaOur extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
Senior Regulatory Affairs Specialist - Vascular (on-site) Abbott LaboratoriesSenior Regulatory Affairs Specialist - Vascular (on-site)Temecula, CAIf you provide content to customers through CloudFront, you can find steps to troubleshoot and help prevent this error by reviewing the CloudFront documentation. Generated by cloudfront CloudFront Request ID: TwCqpv6BvTS-vlIXPJgAp7ukNfx9zn63Emu1GvSBFUGz6uk2CLaUZw.
Senior Specialist, Product Performance, Medical Affairs Abbott LaboratoriesSenior Specialist, Product Performance, Medical AffairsTemecula, CA$99,300–$198,700 / yearMaintains thorough knowledge of assigned devices, drugs, history, and disease states treated to provide scientifically balanced medical devices and drug information to inquiries on Abbott Vascular products and associated disease states from multiple sources, including telephones, letters, faxes, business reply cards and e-mail from internal and external customers. As the Clinical Specialist in the Quality and Product Performance sub-function, considered as highly experienced and knowledgeable resource within the organization in overseeing the direction, planning, execution, clinical trials/research and product quality/safety activities.
Senior Specialist, Product Performance, Medical Affairs AbbottSenior Specialist, Product Performance, Medical AffairsTemecula, CaliforniaMaintains thorough knowledge of assigned devices, drugs, history, and disease states treated to provide scientifically balanced medical devices and drug information to inquiries on Abbott Vascular products and associated disease states from multiple sources, including telephones, letters, faxes, business reply cards and e-mail from internal and external customers. As the Clinical Specialist in the Quality and Product Performance sub-function, considered as highly experienced and knowledgeable resource within the organization in overseeing the direction, planning, execution, clinical trials/research and product quality/safety activities.
Associate Director/Director, Medical Affairs Strategy SolenoAssociate Director/Director, Medical Affairs StrategySan Diego, California$200,000–$265,000 / yearSupport annual medical planning for PWS; work closely across Medical Affairs functions to develop and monitor execution of overall medical strategy and Medical Affairs tactical plans. $200k - $265k (Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the location where this position may be filled.).
Associate Director, State Government Affairs - Remote Agios PharmaceuticalsAssociate Director, State Government Affairs - RemoteSan Diego, CARemote$153,541–$230,312 / yearThe current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
Director of Clinical Affairs Xtant Medical Holdings IncDirector of Clinical AffairsCAMinimum of five (5) years in clinical leadership or management with oversight of clinical staff, multidisciplinary teams, budget and resource planning\n Hands on experience designing, managing, or overseeing clinical trials and clinical studies (early feasibility through post-market), clinical evidence generation strategies, protocol development, CRFs and study reports.\n \n Requires hand-eye coordination and manual dexterity for tasks such as typing\n Ability to see clearly, whether with or without corrective lenses\n Ability to hear and understand safety signals, alarms, and customer requests in a noisy environment\n Ability to safely operate a motor vehicle, including cars, trucks, or commercial vehicles, as required by the position.
NewSenior Director, Medical Affairs Waters CorporationSenior Director, Medical AffairsSan Diego, CAExperience in management of clinical and laboratory-based teams, leading teams remotely and managing projects effectively across geographical sites. • Develop and manage the Clinical Affairs team in support of clinical site selection, study design and execution of clinical trials and analytical validation studies to support regulatory and commercial goals.
Sr Director, Medical Affairs Waters CorporationSr Director, Medical AffairsSan Diego, CAWe collaborate with customers around the world to advance the release of effective, high-quality medicines, ensure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combating antibiotic resistance. Waters Corporation (NYSE:WAT) is a global leader in life sciences and diagnostics, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service.
VP Clinical Affairs Quidelortho CorpVP Clinical AffairsSan Diego, CA$300,000–$350,000 / yearIf the work environment is mainly typically in the lab/warehouse/production line, use verbiage like: The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. We are seeking an accomplished and visionary Vice President of Clinical Affairs to lead the global clinical strategy and operations department for a rapidly growing diagnostics company focused on infectious disease, cardiology, and clinical laboratory innovation.
Director, Federal Government Affairs (Washington D.C./Remote) Illumina, Inc.Director, Federal Government Affairs (Washington D.C./Remote)San Diego, CARemoteFull timeWorking on a team to help cultivate strategic partnerships with public and private payers, provider organizations, key clinical research institutions, and patient advocacy organizations. Third-Party Ally Development - Similarly, build and lead other disparate advocacy coalition efforts to raise awareness of barriers to patient access to therapy and the importance of fostering a business environment friendly to technology innovation, investment, and employment.
Director, Medical Affairs (Pathology/Oncology) Illumina IncDirector, Medical Affairs (Pathology/Oncology)San Diego, CA$224,900–$337,300 / yearThis role will be responsible for actively contributing to product development in Illumina's R&D organization, conducting patient safety risk assessments for Regulatory and Quality teams, supporting product submissions for regulatory approvals, companion diagnostics development for pharma collaborations, and participating in medical education on molecular screening and diagnostics for cancer and hereditary diseases. The individual in this role will represent Medical Affairs within cross-functional teams focused on developing Illumina's instruments, assays, or software for disease screening and diagnostics and, as necessary, work closely with Commercial, Business Development, Pharma, R&D, Product Marketing, Regulatory, Software and Informatics, Assay Development, and Quality teams.
Senior Manager, Medical Affairs Operations - Remote Agios PharmaceuticalsSenior Manager, Medical Affairs Operations - RemoteSan Diego, CARemote$131,035–$196,553 / yearManage the execution of Agios’ patient advocacy conference plans for PK deficiency, thalassemia, and sickle cell disease; participate in cross-functional planning meetings; obtain compliance approval for related materials; and attend virtual and in-person conferences, when needed. Provide operational and project management support to the US patient advocacy team, ensuring smooth day-to-day coordination across priorities, stakeholders, and deliverables, and flex to support various other functions within Medical Affairs as needs arise.
Clinical Affairs Specialist III Thermo Fisher Scientific IncClinical Affairs Specialist IIICarlsbad, CADiscover Impactful Work: This position is part of the Regulatory and Clinical Affairs organization, which ensures that the internal and external work performed to develop our in vitro diagnostics is in compliance with Good Clinical Practice, applicable regulatory requirements (domestically and internationally), and is submitted to the FDA in a complete, accurate, and timely manner for approvals in support of the business units. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Regulatory & Compliance Specialist CorDxRegulatory & Compliance SpecialistSan Diego, CA$90,000–$95,000With over 2,100 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.
Director, Regulatory Strategy (Pediatrics) - Remote Agios PharmaceuticalsDirector, Regulatory Strategy (Pediatrics) - RemoteSan Diego, CARemote$183,549–$275,324 / yearThe current base salary range for this position is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management activities.
Regulatory Strategy Manager Neurocrine Biosciences IncRegulatory Strategy ManagerSan Diego, CA$132,700–$182,000 / yearThe company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in patients with Prader-Willi syndrome, endometriosis and uterine fibroids, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. Requirements: BS/BA degree in Life/Health Sciences AND 6+ years of industry experience of which a minimum of 3 years must be Regulatory Affairs experience in drug development at a research-based pharmaceutical company, including two years in a lead capacity.
Regulatory Coordinator ECN Operating LLCRegulatory CoordinatorSan Diego, CA$24–$30 / hourRegulatory Submissions and Maintenance: Prepare, manage, and submit all required Institutional Review Board (IRB) and other regulatory submissions, including initial protocols, amendments, continuing reviews, safety reports, and close-out documentation. Proficiency with Microsoft Office Suite (Word, Excel, Outlook) and experience with electronic regulatory systems (eReg), CTMS platforms, IRB portals, and document management systems is preferred.
Govt Regulatory Compliance Spec III General AtomicsGovt Regulatory Compliance Spec IIIPoway, CAThe position partners closely with external auditors and government agencies (e.g., DCAA and DCMA) to support Business System reviews, audits, and corrective action efforts, while proactively identifying, assessing, and mitigating compliance gaps and risks. The role serves as a trusted advisor to DFARS Business System stakeholders and senior leadership, interpreting complex regulatory requirements, assessing compliance impacts, and recommending practical, risk-based solutions aligned with business objectives.
Regulatory Compliance Engineer Hunter Industries IncorporatedRegulatory Compliance EngineerSan Marcos, CA$87,000–$95,000 / yearExperience Required and Preferred: Minimum 3 years of experience in Regulatory Compliance, including working with third party agencies for certification and audit of products. Knowledge of Electrical, Manufacturing, and Environmental regulations, such as UL, CE, IEC, SAA, FCC, RCM, RoHs, Reach, WEEE, Energy Star, MEPS, Water Sense, NEMA, IP, etc.
Regulatory Compliance Staff Scientist Terracon Consultants IncRegulatory Compliance Staff ScientistLaguna Hills, CAThis is an excellent opportunity for a highly-motivated individual join a rapidly growing practice and work on local, regional, and national compliance projects across the country. The individual will work on projects in one or more of the service areas below and ideally be familiar with some or all of the general requirements: Stormwater / Stormwater Pollution Prevention Plan (SWPPP).
Regulatory Compliance Assistant Scientist Terracon Consultants IncRegulatory Compliance Assistant ScientistLaguna Hills, CAThis is an excellent opportunity for a highly-motivated individual join a rapidly growing practice and work on local, regional, and national compliance projects across the country. The individual will work on projects in one or more of the service areas below and ideally be familiar with some or all of the general requirements: Stormwater / Stormwater Pollution Prevention Plan (SWPPP).
Govt Regulatory Compliance Spec IV General AtomicsGovt Regulatory Compliance Spec IVPoway, CA53260BRFinance/Accounting 0% - 25% Full-Time Salary California 98,100PowayNo171,398Compliance Specialist Typically requires a bachelor''s degree in business administration with an emphasis in accounting and/or finance, and at least ten years of professional experience in accounting, finance, or similar fields, preferably at a government contractor. The position partners closely with external auditors and government agencies (e.g., DCAA and DCMA) to support Business System reviews, audits, and corrective action efforts, while proactively identifying, assessing, and mitigating compliance gaps and risks.
Regulatory Compliance Engineer Hunter Industries BrandRegulatory Compliance EngineerSan Marcos, CaliforniaKnowledge of Electrical, Manufacturing, and Environmental regulations, such as UL, CE, IEC, SAA, FCC, RCM, RoHs, Reach, WEEE, Energy Star, MEPS, Water Sense, NEMA, IP, etc. Together, we create a diverse array of products that can be seen all over the world, from residential landscapes to national landmarks, stadiums, parks, hotels, and municipal buildings.
Talent Consultant, Remote, Biotech & Lifesciences Experience Ignite Human CapitalTalent Consultant, Remote, Biotech & Lifesciences ExperienceSan Diego, CARemoteThe ideal consultant brings experience recruiting within biotechnology, pharmaceuticals, life sciences, medical devices, CROs, or healthcare organizations and possesses the ability to partner directly with scientific and business leaders to drive workforce growth during critical stages of clinical development and commercialization. The Talent Consultant operates as an embedded extension of the client's talent acquisition function, providing strategic recruiting expertise, workforce planning support, proactive talent sourcing, and full-cycle recruitment services across scientific, clinical, regulatory, commercial, and corporate business functions.
Vice President, Pharmacovigilance Vera Therapeutics IncVice President, PharmacovigilanceSan Diego, CA$300,000–$420,000 / yearVera Therapeutics' lead product candidate is atacicept, a fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN) and lupus nephritis. Working with the internal stakeholders across Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, and Commercial functions to integrate safety strategy throughout the product lifecycle this role will provide strategic and tactical leadership and oversee all aspects of Pharmacovigilance activities through all stages of clinical development as well as post-marketing patient safety.
Associate Medical Director, Medical Safety Jazz Pharmaceuticals PlcAssociate Medical Director, Medical SafetyCarlsbad, CARemote$212,000–$318,000 / yearServe as the signatory and overseer of the preparation and review of pre- and postmarketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-month Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned products. Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy and operational excellence.
Senior Vice President, Clinical Development Qpex Biopharma, IncSenior Vice President, Clinical DevelopmentSan Diego, California$350,000–$400,000 / yearOverview: The Senior Vice President Clinical Development serves as the executive lead, providing strategic and scientific leadership for early development clinical programs, overseeing trial direction, design, execution and data interpretation from first-in-human through early proof-of-concept trials. A demonstrated record of scientific accomplishments and a proven ability to achieve results, experience with supervising projects, excellent knowledge of clinical drug development and latest regulatory guidelines.
Senior Vice President, Clinical Development Qpex Biopharma IncSenior Vice President, Clinical DevelopmentSan Diego, CA$350,000–$400,000 / yearThe Senior Vice President Clinical Development serves as the executive lead, providing strategic and scientific leadership for early development clinical programs, overseeing trial direction, design, execution and data interpretation from first-in-human through early proof-of-concept trials. Primary Duties and Responsibilities include: Responsible for leading the transition of all compounds within the company portfolio from research into clinical development, including early clinical strategy and the design and oversight of early phase clinical trials (Phase 1-2a).
Occupational Safety Manager (Administrator I) San Diego State UniversityOccupational Safety Manager (Administrator I)San Diego, CaliforniaThe Occupational Safety Manager will provide oversight for key occupational safety programs, including workers’ compensation return-to-work initiatives, accident and incident investigations, ergonomics program development, and safety training administration through the University’s Learning Management System. Education Code 89521 Requirements: Applicants will be required to disclose whether they have received a final administrative decision or final judicial decision determining that they have committed sexual harassment within the last 7 years only after a determination is made that they meet the minimum qualifications for the position, and before an offer of employment is extended.
Occupational Safety Manager (Administrator I) CSU CareersOccupational Safety Manager (Administrator I)San Diego, CaliforniaThe Occupational Safety Manager will provide oversight for key occupational safety programs, including workers’ compensation return-to-work initiatives, accident and incident investigations, ergonomics program development, and safety training administration through the University’s Learning Management System. Education Code 89521 Requirements: Applicants will be required to disclose whether they have received a final administrative decision or final judicial decision determining that they have committed sexual harassment within the last 7 years only after a determination is made that they meet the minimum qualifications for the position, and before an offer of employment is extended.
Associate Quality Assurance Manager Carlsmed IncAssociate Quality Assurance ManagerCarlsbad, CA$115,000–$135,000 / yearBachelor degree in Engineering, Life Sciences, Quality Assurance or a related technical discipline or an equivalent combination of education and relevant professional experience 5-8 years of experience in Quality Assurance within a regulated industry Strong working knowledge of ISO 13485, 21 CFR 820 and MDSAP process Direct experience with managing quality system processes such as CAPA, non-conforming products, product release and supplier monitoring Experience in supporting regulatory inspection, internal and external audits ASQ or ISO 13485 lead auditor certification preferred Effective verbal and written communication skills, including the ability to present information to management and auditors. This role will support the Director of Quality Assurance with all quality assurance activities, including document control, audits, CAPA, nonconformance management, and continuous improvement initiatives, while collaborating cross-functionally to support product quality and regulatory compliance.