Danaher Corp is seeking a Regulatory Affairs Senior Specialist for New Product Development, which can be performed remotely. The role involves preparing regulatory submissions, providing leadership to cross-functional teams, and ensuring timely product launches within the life sciences and diagnostics sector
Job Summary
The Regulatory Affairs Senior Specialist serves as the RA lead on New Product Development core teams working on simple to medium complicated assay, instrument, software projects.
This role prepares regulatory submissions including formal written technical reports and interacts cross-functionally to ensure on-time delivery of product launches.
Cepheid offers a broad array of comprehensive benefit programs including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.
Matching Summary
Match Score: 85
Danaher Corp is seeking a Regulatory Affairs Senior Specialist for New Product Development, which can be performed remotely. The role involves preparing regulatory submissions, providing leadership to cross-functional teams, and ensuring timely product launches within the life sciences and diagnostics sector.
Salary
Base: $92,500 - $127,500; Bonus/Equity: Eligible for bonus/incentive pay; Benefits: Comprehensive package including PTO, medical/dental/vision, 401(k)
Skills & Requirements
Must-have
Bachelor's degree with 5+ years experience
Experience supporting 510k submissions
In-depth understanding of regulatory concepts
Nice-to-have
Experience with PMA submissions preferred
Ability to lead core teams on projects
Critical review of study protocols
Key Requirements
5+ years related work experience with Bachelor's degree
3+ years related work experience with Master's degree
0-2 years related work experience with Doctoral degree