About this role
About the Role The Principal Regulatory Affairs Specialist helps develop and execute global regulatory strategies for introducing new and modified IVD medical devices and software. As a subject-matter expert within the Global Regulatory team, you’ll mentor entry-level and intermediate associates and partner with cross-border teams to enable compliant market access. What You'll Do
- Author and lead regulatory filings, registrations, technical files, and listings to obtain global approvals for distribution; collaborate with international colleagues to submit documentation.
- Provide guidance and approve regulatory/quality documentation for new product development deliverables; serve as core team member for regulatory assessments related to design changes, protocols, reports, and marketing materials.
- Assess regulatory risk, interpreting new and existing requirements to align with SOPs and corporate guidance; ensure compliance with agency requirements and standards (FDA/EU IVDR, ISO 13485, 21 CFR Part 820). What We're Looking For
- Bachelor’s degree in chemistry, biochemistry, biology, or related technical field.
- Minimum 7 years in a regulated environment; 4+ years global regulatory experience for in vitro diagnostics.
- Knowledge of U.S. FDA and EU IVD regulations; experience with PMA, de novo, 510(k) and/or technical files.
- Experience with Design Control and Risk Management; working knowledge of ISO 13485, IVDR, and 21 CFR Part 820.
- Strong collaboration/leadership skills and ability to drive global regulatory compliance. Nice to Have
- Proven ability to build consensus and work independently across multiple projects.
- Experience mentoring junior staff and leading cross-functional teams. Compensation & Benefits
- Annual salary range: $110,000 – $135,000. This role is eligible for bonus/incentive pay.
- Remote-friendly work arrangement with comprehensive benefits including medical/dental/vision, paid time off, and 401(k).
- Eligible employees may participate in Danaher benefit programs.