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...
Principal Regulatory Affairs Specialist
A company is looking for a Principal Regulatory Affairs Specialist, US Regulatory Policy. FDA regulatory requirements and policyRegulatory experience within the medical device industry or a regulatory agencyExperience in advocacy related to healthcare policy and regulationsStrong research and analyt...
Staff Regulatory Affairs Specialist - Hybrid
Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Represents the business in interactions with regulatory authori...
Senior Manager Regulatory Affairs
Manager, Regulatory Affairs III to provide strategic direction and operational support for CMC regulatory activities. ...
Director / Senior Director, CMC Regulatory Affairs
Lead global CMC regulatory submission development - responsible for planning, coordinating, and developing high quality, compliant and timely CMC (Quality) regulatory submissions according to current regulatory requirements and guidance to obtain efficient and timely regulatory approvals (IND/IMPD, ...
Senior Manager, Regulatory Affairs
Liaise with colleagues in Regulatory Affairs therapeutics teams, company local Affiliates, Regulatory Operations, Regulatory Project Management and third-party local agents to develop filing plans and deliver submissions to agreed priorities and timelines. Senior Manager, Regulatory Affairs III. Sen...
Regulatory Affairs Specialist
Job Description: Regulatory Affairs Specialist - On-site 5x a week in Alameda, CA. Provide consultation and advice to regulatory specialists regarding change control and product development. Contribute to continuous improvement initiatives within the regulatory affairs function. Experience with Japa...
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...
Senior Regulatory Specialist
The Southern California Natural Resources Team is looking for an experienced Regulatory Specialist to support permitting needs, including:. You will join an existing team of Natural Resources professionals that includes wildlife biologists, botanists, aquatic resource biologists (waters, wetlands, a...