NewR&D Scientist CTK OTC Laboratories LLCR&D ScientistCorona, CAFull timeSupport OTC monograph alignment, active-ingredient controls, Drug Facts and claims documentation, cGMP batch records, in-process controls, and product specifications in coordination with Regulatory Affairs and Quality. · Translate customer and marketing briefs into prototypes by selecting appropriate actives, emulsifiers, surfactants, rheology modifiers, preservatives, and sensory-enhancing ingredients.
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.
Associate Specialist - Premarket Regulatory Affairs (Global) Applied Medical Resources CorpAssociate Specialist - Premarket Regulatory Affairs (Global)Rancho Santa Margarita, CA$70,000–$80,000 / yearOur unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute to a larger capacity than is possible in typical positions. Join Applied Medical as an Associate Specialist in Premarket Regulatory Affairs and help shape the future of medical innovation across our global markets.
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.
Associate Specialist – Premarket Regulatory Affairs (Global) Applied MedicalAssociate Specialist – Premarket Regulatory Affairs (Global)Rancho Santa Margarita, CA$70,000–$80,000 / yearOur unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute to a larger capacity than is possible in typical positions. Join Applied Medical as an Associate Specialist in Premarket Regulatory Affairs and help shape the future of medical innovation across our global markets.
Principal Regulatory Affairs Specialist - Vascular (on-site) Abbott LaboratoriesPrincipal Regulatory Affairs Specialist - Vascular (on-site)Temecula, CA$100,000–$200,000 / yearThe Principal Regulatory Affairs Specialist will manage complex regulatory activities, including on-market product support, product development projects, lifecycle management initiatives, regulatory assessments, and global submissions. The candidate will have demonstrated experience preparing and executing regulatory strategies, supporting interactions with regulatory authorities and notified bodies, and successfully obtaining regulatory approvals for medical devices in the U.S., E.U. and other international markets.
Principal Regulatory Affairs Specialist – Vascular (on-site) AbbottPrincipal Regulatory Affairs Specialist – Vascular (on-site)Temecula, South CarolinaThe Principal Regulatory Affairs Specialist will manage complex regulatory activities, including on-market product support, product development projects, lifecycle management initiatives, regulatory assessments, and global submissions. The candidate will have demonstrated experience preparing and executing regulatory strategies, supporting interactions with regulatory authorities and notified bodies, and successfully obtaining regulatory approvals for medical devices in the U.S., E.U. and other international markets.
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 Regulatory Affairs Specialist – Vascular (on-site) AbbottSenior Regulatory Affairs Specialist – Vascular (on-site)Temecula, South Carolina$90,000–$180,000 / 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. 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 Specialist, Product Performance, Medical Affairs AbbottSenior Specialist, Product Performance, Medical AffairsTemecula, California$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 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 Spectrum Engineer, Regulatory Affairs Viasat, Inc.Senior Spectrum Engineer, Regulatory AffairsCarlsbad, California$180,500–$285,000 / yearFull timeFor specific work locations within San Jose, the San Francisco Bay area and New York City metropolitan area, the base pay range for this role is $224,500.00- $336,500.00/ annually: At Viasat, we consider many factors when it comes to compensation, including the scope of the position as well as your background and experience. Multi-Orbit & Next-Gen Architecture: Deep technical understanding of non-geostationary (NGSO) constellation dynamics, spectrum sharing paradigms, or emerging satellite-to-cell (Direct-to-Device) frameworks.
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.
Clinical Affairs Specialist III Thermo Fisher ScientificClinical Affairs Specialist IIICarlsbad, CaliforniaThis 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 world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Associate Director, Regulatory and Medical Writer Ionis Pharmaceuticals IncAssociate Director, Regulatory and Medical WriterCarlsbad, CARemote$142,588–$201,472 / yearRESPONSIBILITIES: Working with the Executive Director, Regulatory and Medical Writing, lead the development, authoring, and delivery of complex regulatory documents such as clinical study reports and marketing application summary documents (Module 2), and lead and/or contribute to Investigator's Brochures, clinical study protocols, and briefing documents. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.
Associate Medical Director, Medical Safety Jazz Pharmaceuticals PlcAssociate Medical Director, Medical SafetyCarlsbad, CA$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.
Marriage and Family Therapist (Advanced) U.S. Department of Veterans AffairsMarriage and Family Therapist (Advanced)Oceanside, CA$102,246–$132,923 / yearThe Department of Veterans Affairs performs pre-employment reference checks as an assessment method used in the hiring process to verify information provided by a candidate (e.g., on resume or during interview or hiring process); gain additional knowledge regarding a candidates abilities; and assist a hiring manager with making a final selection for a position. If you are currently serving on active duty and expect to be released or discharged within 120 days you must submit documentation related to your active duty service which reflects the dates of service, character of service (honorable, general, etc.), and dates of impending separation.
Marketing Manager, Clinical Marketing & Sales Enablement Exagen Diagnostics IncMarketing Manager, Clinical Marketing & Sales EnablementCarlsbad, CA$120,000–$160,000 / yearThis role develops clinically accurate, commercially effective content and tools that support the sales team, healthcare professionals, patients and Exagen's broader marketing objectives. Exagen's laboratory specializes in the testing of rheumatic diseases, delivering precise and timely results, supported by a full suite of AVISE-branded tests for disease diagnosis, prognosis, and monitoring.