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.
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.
Water Quality/Regulatory Affairs Supervisor Palmdale Water DistrictWater Quality/Regulatory Affairs SupervisorPalmdale, CA$75.78–$87.87 / hourParticipate in development of improved water treatment processes and review monitoring programs related to water supply, distribution and storage; recommend changes in monitoring programs, treatment methods or process control. To plan, organize, direct, and supervise water quality laboratory operations and related regulatory compliance activities within the Operations Department; and to perform a variety of technical tasks relative to assigned area of responsibility.
Senior Manager, Medical Affairs Operations - Remote Agios PharmaceuticalsSenior Manager, Medical Affairs Operations - RemoteLos Angeles, 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.
NewQuality Systems & Regulatory Manager JobotQuality Systems & Regulatory ManagerLos Angeles, CA$90,000–$120,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. They’re looking for a tech-savvy and detail-oriented Quality Systems & Regulatory Manager to lead food safety systems, labeling accuracy, customer compliance documentation, and cross-functional audit readiness.
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.
Associate Director, State Government Affairs - Remote Agios PharmaceuticalsAssociate Director, State Government Affairs - RemoteSan Jose, 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.
NewGeneral Manager LUV Car WashGeneral ManagerSanta Rosa, CAThe General Manager (GM) is responsible for all site operations including recruiting of staff, site safety, facilities management, customer service, driving sales, site compliance and the development of the car wash team. Partner with Facilities to ensure all equipment is properly maintained, safely operated and maintenance requests are fulfilled in a timely manner to minimize site downtime.
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.
NewPlant Quality Manager CONAGRAPlant Quality ManagerOakdale, CA$109,000–$159,000Lead food safety and quality programs, including Hazard Analysis and Critical Control Points, Safe Quality Food certification, recall programs, environmental monitoring, and pest control programs. Reporting to the Director, Food Safety Quality and Regulatory Affairs, you will lead food safety and quality programs at our Oakdale, California manufacturing facility, a local producer of Hunt’s tomato products.
NewPrincipal Experience Designer - Contract TalentBurst, Inc.Principal Experience Designer - ContractSouth San Francisco, CA$91.03–$104.51 / hourThis combined team, in collaboration with key partners, builds solutions to serve Marketing, Customer Engagement, Medical Affairs, Public Affairs & Access ("CMG”), and other patient- and customer-facing teams across CMG to shape and drive a seamless, consistent, meaningful, and compliant experience for patients and customers across our interactions. As healthcare evolves, we are bold in our approach – leveraging cutting edge AI, advanced digital engagement, end-to-end content management, and omnichannel technologies and operations to create seamless, personalized, and meaningful experiences for our patients and customers.
Regulatory Affairs Manager I Alcon IncRegulatory Affairs Manager ILake Forest, CAThe Manager I, Regulatory Affairs Strategy (Professional Path) ), reporting to the Senior Manager of Regulatory Affairs (LLSI), is primarily responsible for coordinating regulatory affairs activities, including product submissions, renewals, and updates, while ensuring compliance and competitive advantage. Collect and analyze regulatory intelligence for China to ensure product compliance and engage in industry associations like Advanced Medical Technology Association (AdvaMed) and Asia Pacific Medical Technology Association (APACMed).
Regulatory Affairs Manager - International Compliance Operations – Diabetes Care (on-site) AbbottRegulatory Affairs Manager - International Compliance Operations – Diabetes Care (on-site)Alameda, CaliforniaLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Maintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicates such knowledge to all internal stakeholders.
NewRegional Director - Anesthesiology - Vituity Practice Management - Emeryville VituityRegional Director - Anesthesiology - Vituity Practice Management - EmeryvilleEmeryville, CACommit to creating and demonstrating inclusivity within Vituity including codesigning, building, and executing strategies, policies, and practices that cultivate equity, inclusion, and fair opportunity for all; demonstrating preparedness to educate, mitigate, coach, and address daily bias and exclusion in partnership with the site leadership. Accountable for ensuring meaningful integration occurs: Identify opportunities for practice line integration to ensure the quality and efficiency of patient care delivery across the acute care continuum; assist with new service line startups; engage regularly with integrated site RDs.
NewBilingual Korean/English Senior Regulatory Affairs Manager - Cosmetics, OTC & Supplements (FDA Compliance Macpower Digital Assets Edge Private LimitedBilingual Korean/English Senior Regulatory Affairs Manager - Cosmetics, OTC & Supplements (FDA ComplianceLos Angeles, CA$90,000–$140,000 / yearGuided by the core values of Beautiful, Healthy, and Refreshing , they innovate beyond traditional cosmetics and household products, delivering creative solutions tailored to evolving consumer needs. As the Senior Regulatory Affairs Manager , you will ensure regulatory compliance for cosmetic, OTC, dietary supplement, and medical device products in North America—from concept to market launch.
Regulatory Affairs Manager – APAC - Diabetes Care (on-site) AbbottRegulatory Affairs Manager – APAC - Diabetes Care (on-site)Alameda, CaliforniaYou will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region. This Regulatory Affairs Manager – APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.
Regulatory Affairs Manager - APAC - Diabetes Care (on-site) Abbott LaboratoriesRegulatory Affairs Manager - APAC - Diabetes Care (on-site)Alameda, CA$114,000–$228,000 / yearYou will be responsible for managing a small team overseeing the Diabetes Care product portfolio in the APAC region, creating robust global regulatory strategies, working with cross-functional teams as the regulatory SME, provide support for compiling regulatory submissions, and ensuring data is effectively presented for the registration of products in the APAC region. This Regulatory Affairs Manager - APAC position will work closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure efficient and compliant business processes and environment.
Policy & Regulatory Affairs Manager Zoox IncPolicy & Regulatory Affairs ManagerFoster City, CA$137,000–$187,000 / yearThe Policy and Regulatory Affairs at Zoox is a cross-functional organization responsible for advancing Zoox's public policy, regulatory, and political goals, including working with state regulatory agencies, legislators, executive branch, and policymakers. Exceptional project management and organizational skills, with experience successfully supporting the execution of multiple complex, cross-functional projects simultaneously.
NewSenior Regulatory Affairs Manager (Onsite) CordxSenior Regulatory Affairs Manager (Onsite)San Diego, CAWith 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. The Senior Regulatory Affairs Manager will play a crucial role in leading and managing the regulatory submissions for CorDx medical device products, including 510(k) and submissions.
Regulatory Affairs Manager I Alcon ResearchRegulatory Affairs Manager ILake Forest, CaliforniaThe Manager I, Regulatory Affairs Strategy (Professional Path) ), reporting to the Senior Manager of Regulatory Affairs (LLSI), is primarily responsible for coordinating regulatory affairs activities, including product submissions, renewals, and updates, while ensuring compliance and competitive advantage. Collect and analyze regulatory intelligence for China to ensure product compliance and engage in industry associations like Advanced Medical Technology Association (AdvaMed) and Asia Pacific Medical Technology Association (APACMed).
NewDialysis Facility Administrator U.S. Renal CareDialysis Facility AdministratorChula Vista, CA$110,947–$166,421Additionally, if the nursing requirements listed below are not met, an individual may be placed in the Administrator role without them; however, in the absence of these qualifications, there must be a designated Registered Supervising Nurse at the clinic who does possess these qualifications: Must be full-time employee of the Company and available to clinic staff during time clinic is open. · Continuously monitor to ensure that a safe and sanitary physical environment is maintained throughout the facility; that all equipment is maintained and functions properly; and that adequate and appropriate inventory levels of all supplies are available and used correctly.
NewSenior Director, Clinical Education and Events Dentsply SironaSenior Director, Clinical Education and EventsSan Jose, CAThis leader serves as the senior clinical authority for NAM education, ensuring programs meet the needs of practicing clinicians while supporting business priorities, product adoption, and long term customer trust. • Oversee planning and execution of clinical educational events (e.g., courses, workshops, symposia, webinars), ensuring end-to-end operational excellence (logistics, faculty coordination, attendee experience) and alignment to learning objectives.
Regulatory Affairs Manager - Vascular (on-site) Abbott LaboratoriesRegulatory Affairs Manager - Vascular (on-site)Santa Clara, CA$114,000–$228,000 / yearThe candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured or distributed to meet required legislation. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
Policy & Regulatory Affairs Manager ZooxPolicy & Regulatory Affairs ManagerFoster City, CAThe Policy and Regulatory Affairs at Zoox is a cross-functional organization responsible for advancing Zoox's public policy, regulatory, and political goals, including working with state regulatory agencies, legislators, executive branch, and policymakers. The Policy and Regulatory Affairs Manager will support Zoox’s state policy portfolio, providing important project management, public policy analysis, and help to implement Zoox’s state policy strategy.
Regulatory Affairs Manager Katalyst Healthcares & Life SciencesRegulatory Affairs ManagerIrvine, CAResponsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions.
Regulatory Affairs Manager Karwell TechnologiesRegulatory Affairs ManagerIrvine, CAResponsibilities: In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA (FDA), EU (MDR), China (NMPA), and more. You will work cross-functionally with Clinical, Global Regulatory Affairs counterparts, and others to support innovation and expand market access for our advanced ultrasound technologies and solutions.
Senior Manager, Regulatory Affairs - Lingo (on-site) Abbott LaboratoriesSenior Manager, Regulatory Affairs - Lingo (on-site)Alameda, CA$130,700–$261,300 / yearOur portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance.
Senior Manager, Regulatory Affairs Strategy Alcon IncSenior Manager, Regulatory Affairs StrategyLake Forest, CAManager, Regulatory Affairs Strategy (Professional Path), reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for setting or executing the regulatory strategy, leading and managing, acting as a strategist, ensuring local product registration and facilitating health registration approvals, and supporting the Senior Director during due diligence and integration activities for Business Development & Licensing projects. In this role, a typical day will include: A self-starter, assertive leader who will be accountable for the End-to-End regulatory support for the anterior/posterior ophthalmologic products including, but not limited to, new products, sustaining legacy products, and improvements to the product lines.
Manager, Regulatory Affairs Jade BiosciencesManager, Regulatory AffairsSan Francisco, CaliforniaRemote$135,000–$150,000 / yearJade’s pipeline also includes JADE201, an afucosylated anti-BAFF-R monoclonal antibody, as well as JADE301, an undisclosed antibody candidate, both currently in preclinical development. Participate in the review of key clinical and nonclinical documents (protocols, IBs, CSRs, DSURs, etc.) to ensure alignment with regulatory obligations and relevant guidelines (ICH, FDA, EMA, ROW).
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.
Regulatory Affairs Manager – Diabetes Care (on-site) AbbottRegulatory Affairs Manager – Diabetes Care (on-site)Alameda, CaliforniaAs a member of the U.S. Regulatory Affairs management team, the successful candidate will lead and develop talent, shape regulatory strategy, and partner across functions to bring innovative products to market, whilst driving regulatory excellence for the manufacture, change management, and ongoing supply of the Libre portfolio. Drive and provide strategic guidance on FDA pathways, submissions, and interactions, including pre-submissions, 510(k), PMA, and post-market activities.
Manager II, Regulatory Affairs Strategy Alcon IncManager II, Regulatory Affairs StrategyCA$105,000–$175,000 / yearYou will support regulatory strategy execution with a focus on medical device consumables and accessories within the Surgical franchise, partnering cross‑functionally to ensure alignment with evolving regulatory expectations. Our benefits program provides security for life events through life and disability insurance, supports savings for retirement, promotes good health and well-being and supports associates and their families during times of illness.
Regulatory Affairs Sr Manager, Regulatory Promotion & Material Compliance Amgen IncRegulatory Affairs Sr Manager, Regulatory Promotion & Material ComplianceThousand Oaks, CAIn addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.
Regulatory Affairs Manager - International Compliance Operations - Diabetes Care (on-site) Abbott LaboratoriesRegulatory Affairs Manager - International Compliance Operations - Diabetes Care (on-site)Alameda, 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: HApWOKJEzq0IQxi15tNrlpXMJkFtE7qhBCo6PVler_t91rUjMytuOw.
Manager II, Regulatory Affairs the Tarsanet Internal Career CenterManager II, Regulatory AffairsIrvine, CaliforniaRemoteAssist in performing and managing the initial part of the workflow (Initial QC, routing, scheduling meetings, etc.) in the Veeva system for material review and approval of the materials submitted from the assigned business units. Serve as the Regulatory point of contact for the regulatory promotional perspective and rationale at regulatory project team meetings, labeling meetings, brand team meetings, as needed.
Senior Manager, Regulatory Affairs Strategy Alcon ResearchSenior Manager, Regulatory Affairs StrategyLake Forest, CaliforniaManager, Regulatory Affairs Strategy (Professional Path), reporting to the Senior Director of Regulatory Affairs (LLSI), is primarily responsible for setting or executing the regulatory strategy, leading and managing, acting as a strategist, ensuring local product registration and facilitating health registration approvals, and supporting the Senior Director during due diligence and integration activities for Business Development & Licensing projects. A self-starter, assertive leader who will be accountable for the End-to-End regulatory support for the anterior/posterior ophthalmologic products including, but not limited to, new products, sustaining legacy products, and improvements to the product lines.
Manager II, Regulatory Affairs Tarsus Pharmaceuticals IncManager II, Regulatory AffairsIrvine, CARemote$120,000–$168,000 / yearLet's talk about some of the key responsibilities of the role: Assist in performing and managing the initial part of the workflow (Initial QC, routing, scheduling meetings, etc.) in the Veeva system for material review and approval of the materials submitted from the assigned business units. A Few Other Details Worth Mentioning: The position can be either Remote or based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals.
Senior Manager Regulatory Affairs US Advertising and Promotion - US Specialty AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - US SpecialtyIrvine, CAOversees the operations productivity and development of assigned regulatory staff that are responsible for ensuring that advertising and promotion materials are accurate, competitive and compliant with internal policies, Code of Federal Regulations (CFR), FDA guidance documents, PhRMA Guiding Principles, and the Federal Food, Drug, and Cosmetic Act. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Senior Manager Regulatory Affairs US Advertising and Promotion - Immunology AbbVie IncSenior Manager Regulatory Affairs US Advertising and Promotion - ImmunologyIrvine, CAApplicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
Regulatory Affairs Quality/Standards/Training Manager - Remote Roth Staffing CompaniesRegulatory Affairs Quality/Standards/Training Manager - RemoteAlameda, CaliforniaRemote$85–$93.68 / hourCollaborate with Quality Assurance and cross‑functional stakeholders to support health authority inspections across GPS and Regulatory Affairs, ensuring the RA function remains in a continuous state of inspection readiness. · Work with Regulatory Affairs Strategist, CRO and Clinical Operations to ensure the Trial Master File (TMF) and Veeva RIM is kept current and complete for Regulatory Affairs-related documents.
Regulatory Affairs & Quality Assurance Manager University of California, IrvineRegulatory Affairs & Quality Assurance ManagerOrange, CaliforniaFull timeResponsibilities: Under the general direction of the Assistant Director of Clinical Research Operations of the UCI Center for Clinical Research (CCR), the Manager of Regulatory Affairs and Quality Assurance is responsible for all clinical research regulatory and quality assurance operational matters in fulfilling the mission of CCR under the University of California, Irvine - School of Medicine and the overall UC Irvine Health enterprise. *Misconduct Disclosure Requirement: As a condition of employment, the final candidate who accepts a conditional offer of employment will be required to disclose if they have been subject to any final administrative or judicial decisions within the last seven years determining that they committed any misconduct; received notice of any allegations or are currently the subject of any administrative or disciplinary proceedings involving misconduct; have left a position after receiving notice of allegations or while under investigation in an administrative or disciplinary proceeding involving misconduct; or have filed an appeal of a finding of misconduct with a previous employer.
Senior Manager, Regulatory Affairs - Lingo (on-site) AbbottSenior Manager, Regulatory Affairs - Lingo (on-site)Alameda, CaliforniaOur portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance.
Senior Manager, Commercial Regulatory Affairs Revolution Medicines IncSenior Manager, Commercial Regulatory AffairsRedwood City, CA$164,000–$205,000 / yearThe company's RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As part of the Regulatory Affairs function, the Senior Manager will work under supervision to provide strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products in accordance with business goals and objectives, FDA regulations/guidances, pharma guidelines, and company policy.
Senior Manager, Commercial Regulatory Affairs Revolution MedicinesSenior Manager, Commercial Regulatory AffairsRedwood City, CaliforniaThe company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As part of the Regulatory Affairs function, the Senior Manager will work under supervision to provide strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products in accordance with business goals and objectives, FDA regulations/guidances, pharma guidelines, and company policy.
Manager, Product Integrity, Regulatory & Scientific Affairs Noodle & Boo, Inc.Manager, Product Integrity, Regulatory & Scientific AffairsCerritos, CANoodle & Boo is seeking a highly organized, scientifically rigorous, and detail-oriented Manager, Product Integrity, Regulatory & Scientific Affairs to support the day-to-day execution of formula governance, regulatory documentation, product compliance, technical recordkeeping, claims substantiation, COA review, and manufacturing quality consistency across our premium baby, maternity, and family care portfolio. Reporting to the Founder and ultimately the VP Product / Chief Product Officer, this role is cross-functional and operationally important, but remains a manager-level, hands-on role focused on execution, documentation control, quality follow-up, and compliance support.
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).
Senior Manager, Regulatory Affairs TMTT Edwards LifesciencesSenior Manager, Regulatory Affairs TMTTIrvine, CA$145,000–$205,000 / yearWorking in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives. Includes representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including providing alternatives for meeting regulatory requirements and resolving complex conflicts between those requirements and development issues.
Manager, Regulatory Affairs iRhythmManager, Regulatory AffairsSan Francisco, CaliforniaRemoteLead FDA submissions (510(k) or pre-submissions) with the team, including wearable devices, as well as artificial intelligence (AI) Software as a Medical Device (SaMD) products. There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist.
New(Senior) Manager, Regulatory Affairs Braveheart Bio(Senior) Manager, Regulatory AffairsSan Francisco, CA$119,000–$190,000 / yearOur lead product candidate, BHB-1893, is a next-generation oral small-molecule cardiac myosin inhibitor (CMI) being developed for the treatment of obstructive HCM (oHCM) and non-obstructive HCM (nHCM). Reporting into the Vice President of Regulatory Affairs, this individual will manage the CRO(s) responsible for preparing CTAs, as well as coordinate preparation of cross-functional deliverables and manage health authority queries and responses.
Manager, Regulatory Affairs CMC Iovance Biotherapeutics IncManager, Regulatory Affairs CMCSan Carlos, CARemote$140,000–$160,000 / yearMental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines. Organizational and planning skills; ability to influence and negotiate professionally at various levels within the project team and with external partners while maintaining positive working relationships.