- Hybrid Position located in San Diego, CA
- Candidates willing to relocate are encouraged to apply
Senior Regulatory Affairs Specialist
As a Regulatory Affairs Specialist, you will manage the collection of technical data and prepare submissions for in vitro diagnostic (IVD) and medical device licenses to regulatory agencies.
Key Responsibilities:
- Oversee the submission and review of documents for Design History files.
- Draft, edit, and compile technical documentation and design dossiers to support CE/UKCA mark regulatory submissions.
- Prepare post-market surveillance reports for medical devices.
- Prepare EU/UK vigilance reports as needed.
- Prepare and submit regulatory documents for FDA approvals.
- Assist with the registration and application of Class II & III Medical Device Licenses for Health Canada.
- Research and interpret FDA, CMDR, MDR, IVDR, and UK MDR2002 regulations for regulatory compliance.
- Review and ensure labeling, packaging, and marketing materials meet FDA and CE requirements.
- Maintain and update regulatory documentation and standards.
- Ensure the Essential Requirements Checklists are up-to-date with current standards.
- Provide technical documentation to Competent Authorities and Notified Bodies.
- Support OEM customers in obtaining CE marks for their products.
Qualifications:
- Bachelor's degree in a related field or equivalent experience.
- Minimum of 6 years of experience in the IVD industry, with at least 3 years focused on preparing and submitting 510(k) for IVD devices.
- In-depth knowledge of medical device regulations.
- Ability to create clear and comprehensive technical documentation.
- Analytical skills with experience in summarizing data.
- Proficiency in Microsoft Office.
- Strong project management and multitasking skills.
- Familiarity with QSRs, ISO 13485, IVDD/IVDR, MDD/MDR, UK MDR 2002, CMDR, GMP, and 21 CFR standards.
