Overseeing compliance inspections for an investment management company. Supporting the development and maintenance of compliance processes and providing guidance on regulatory implications.
About the role
- Principal Regulatory Affairs Specialist at Philips developing regulatory strategy for SaMD products. Overseeing compliance and regulatory submissions in FDA and international markets.
Responsibilities
- Develop and execute the regulatory strategy for new product development, design changes, and field safety corrections
- Author 510K submissions, pre-sub documents, EUMDR tech files, and contribute to international regulatory submissions
- Participate in strategic product development, design solutions from concept phase to product delivery phase
- Provide regulatory guidance throughout design and development
- Act as a Regulatory Subject Matter Expert (SME) and manage special projects across product lines
- Monitor global regulatory landscapes and guide cross-functional teams on regulation changes
- Communicate new changes and facilitate interpretation to ensure compliance
- Support product defect assessments, health hazard evaluations, corrections and removals as a regulatory SME
- Review labeling, marketing materials, and claims substantiation evidence
Requirements
- Minimum of 7+ years' experience in Regulatory Affairs/Strategy within FDA regulated Medical Device environments
- Proven expertise in Software as a Medical Device (SaMD), IEC 82304 (safety) and IEC 81001-5-1/ISO 27001 (Information Security)
- Experience authoring multiple 510Ks, EUMDR tech files, and Pre-Sub notifications submitted to the FDA
- Familiarity with FDA, EU MDR, Health Canada, and other relevant international regulatory standards and regulations
- Knowledge and understanding of the software development lifecycle (SDLC)
- Minimum of a Bachelor's Degree (Required)
- RAPS certification - preferred
- Proven ability to build strong relationships with internal and external stakeholders
Benefits
- Generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- Stock purchase plan
- Education reimbursement
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