Regulatory Affairs Principal, IVD
Listed on 2025-11-10
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Software Development
Data Science Manager
Kelly Science, Engineering, Technology & Telecom provided pay range
This range is provided by Kelly Science, Engineering, Technology & Telecom. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range$60.00/yr - $63.00/yr
Position OverviewKelly Science & Clinical is recruiting a Regulatory Affairs Principal for an 18-month contract with a leading molecular diagnostics company in Sunnyvale, CA. This role involves translating scientific discoveries into advancements and advancing your career in biotech.
Workplace and Position DetailsWorkplace: Remote (USA)
Position Title: Regulatory Affairs Principal, New Product Development
Pay rate: $60-63/hour
Role SummaryThe Regulatory Affairs Principal leads on New Product Development (NPD) teams, working on assay, instrument, software, and system projects. Responsibilities include preparing regulatory submissions, ensuring on-time product launches, and collaborating across functions to introduce new products and foster career growth within Regulatory Affairs.
Key Responsibilities- Regulatory Submissions: Manage submissions for US and EU IVDR and WHO PQ, ensuring compliance and timely launch.
- Agency Interaction: Communicate with regulatory agencies and authorities to address queries and obtain approvals.
- Regulation Interpretation: Interpret new regulations affecting US and EU markets.
- Continuous Improvement: Use DBS tools to improve processes within regulatory domain.
- Reporting: Prepare reports and presentations on strategies and project status.
- Qualifications: Bachelor's degree with 8+ years, Master's with 6+ years, Doctorate with 3+ years of relevant experience.
- Project Leadership: Lead NPD core teams for complex projects.
- Regulatory Strategy: Develop strategies for product launches in US, EU, and WHO markets.
- Documentation: Prepare regulatory submissions including FDA pre-submissions, 510(k), and PMA.
- CLIA waiver experience is a plus.
- Seniority level: Mid-Senior level
- Employment type: Full-time
- Job function: Consulting, Quality Assurance, and Science
- Industries: Research Services, Biotechnology Research, Medical Equipment Manufacturing
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