A company is looking for a Senior Regulatory Affairs Specialist, Medical Devices.Key ResponsibilitiesProvide regulatory strategic leadership for medical device products, including AI / ML-enabled devicesLead regulatory submission teams and guide cross-functional teams on regulatory decision-makingConduct regulatory training programs on relevant topics and review device labeling for complianceRequired QualificationsBachelor's degree in a technical or scientific field8+ years of experience in Regulatory Affairs submissions for medical devices and digital health productsExperience with FDA regulations and international standards for medical devicesTechnical proficiency in at least two relevant product categoriesAdvanced degree or regulatory certifications preferred
Senior Counsel Product and Regulatory Affairs
A company is looking for a Senior Counsel, Product and Regulatory Affairs (Liquidity). ...
Senior Regulatory Affairs Specialist (IVD)
We are hiring a Senior Regulatory Specialist for an established in-vitro diagnostics company in San Diego, CA. This is hybrid on-site role 3 days per week and requires at least 5-7+ years of hands-on Regulatory experience including 510(k) authorship. Drafts, edits and compiles technical documentatio...
Regulatory Affairs Specialist
A company is looking for a Regulatory Affairs Specialist I to manage regulatory documentation and submissions. ...
Senior Specialist - Regulatory Affairs - Sharp Memorial Hospital - Day - Full-time
Seeking a detail-oriented (preferably experienced) Regulatory Affairs Senior Specialist to join our regulatory department. Work closely with hospital administration, clinical departments, and external regulatory agencies to develop, implement, and monitor compliance initiatives, policies, and proced...
Senior Manager Regulatory Affairs
Manager, Regulatory Affairs III to provide strategic direction and operational support for CMC regulatory activities. ...
Senior Director or Vice President of Regulatory Affairs
We are in search of an accomplished and dynamic Senior Director of Regulatory Affairs to join our team. Reporting directly to the Chief Medical Officer, the Senior Director will provide strategic leadership, ensuring compliance with global regulatory standards while supporting organizational objecti...
Sr. Regulatory Affairs Specialist I
Responsible for the preparation and maintenance of domestic and international regulatory filings to meet corporate objectives and for the timely completion of other assigned activities related to regulatory support activities including all programs related to FDA and QSR compliance. Works with Regul...
Regulatory Affairs Specialist 3
Bachelor's Degree required in the life sciences or engineering with a minimum of 5-8 years direct experience in Regulatory Affairs within an IVD or Drug/Biologics Industry. Master’s Degree and/or RAC preferred with a minimum of 3-5 years direct experience in Regulatory Affairs within an IVD or Drug/...
Staff Regulatory Affairs Specialist, Infusion - Remote
Review changes and related documentation to assure collection of appropriate data for regulatory submissions and regulatory compliance. Minimum 5 years of strong Regulatory Affairs experience in the medical device industry. Proven prior experience required owning and managing the end-to-end process ...
Senior/Principal Regulatory Specialist (Hybrid)
Senior/Principal Regulatory Specialist (Hybrid). Lead regulatory strategy and submissions (PMA, IDE) for Class III medical devices. Support global regulatory registrations and maintain compliance. Senior: $100k-$150k + equity and bonus. ...