Danaher Corporation · 2 months ago
Regulatory Affairs Principal
Sunnyvale, California, United States
Full-time
Hybrid
Senior Level, Lead/Staff
$135K/yr - $190K/yr
6+ years expCepheid, a Danaher operating company, is focused on improving health care through fast, accurate, molecular diagnostic systems and tests. The Regulatory Affairs Principal will lead regulatory efforts on new product development projects, ensuring compliance and timely product launches while interacting with regulatory agencies.
BiotechnologyHealth CareHealth DiagnosticsLife ScienceMedical
Responsibilities
Prepare regulatory submissions and interact cross-functionally on new product core teams to ensure On Time Delivery (OTD) of product launches
Interact with regulatory agencies/health authorities to resolve queries and to obtain product approvals with a focus on US and EU IVDR and WHO PQ submissions as required
Serves as representative to gather and interpret new and changed regulations and guidelines in the US and EU
Implements continuous improvements and efficiencies using DBS tools
Serves as RA lead on new product (NPD) core teams including medium to complicated assay, instrument or software projects and complies, prepares, reviews, and submits regulatory submissions (Pre-submissions, 510(k), De Novo, PMA, IVDR Class A, B, C or D or WHO PQ)
Critical review of study protocols and reports to assess quality, clearly identify gaps, and provide mitigations
Actively participates in project core teams, developing regulatory strategy and plans and collaboratively achieving project goals and meeting timelines
Prepares formal written reports, PowerPoint presentations to communicate regulatory strategies and status
Qualification
Required
Bachelor's degree in applicable fields (such as biological sciences, biomedical engineering, or chemistry) with 8+ years of related work experience OR Master's degree in applicable field with 6+ years of related work experience OR Doctoral degree in applicable field with 3+ years of related work experience
Serves as RA lead on new product (NPD) core teams including medium to complicated assay, instrument or software projects and complies, prepares, reviews, and submits regulatory submissions (Pre-submissions, 510(k), De Novo, PMA, IVDR Class A, B, C or D or WHO PQ)
Critical review of study protocols and reports to assess quality, clearly identify gaps, and provide mitigations
Actively participates in project core teams, developing regulatory strategy and plans and collaboratively achieving project goals and meeting timelines
Prepares formal written reports, PowerPoint presentations to communicate regulatory strategies and status
Potential travel either domestic or international may be required up to 25%
Preferred
Uses extensive experience and regulatory intelligence information and product knowledge to develop regulatory strategy for submissions
Ensuring design controls are met
Benefits
Paid time off
Medical/dental/vision insurance
401(k)
Company
Danaher Corporation
Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
unknown1979-01-05IPO
Leadership Team
Rainer Blair
President & CEO
Thomas Joyce
President & CEO
Recent News
Mobihealthnews
2026-01-16
2026-01-14
Company data provided by crunchbase