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Senior Regulatory Affairs Manager, IVD & Medical Devices

Job in Northern, Floyd County, Kentucky, USA
Listing for: RXinsider LTD.
Full Time position
Listed on 2026-10-07
Job specializations:
  • Healthcare
    Healthcare Compliance, Healthcare Management
Salary/Wage Range or Industry Benchmark: 170000 - 185000 USD Yearly USD 170000.00 185000.00 YEAR
Job Description & How to Apply Below
Location: Northern

Quidel Ortho is seeking a Senior Regulatory Affairs Manager to lead regulatory activities for new in vitro diagnostics and medical devices, managing US FDA submissions and global registrations. This role requires extensive GMP/QMS knowledge and experience interacting with regulatory agencies.

The position is remote eligible for candidates in the United States, with a salary range of $170,000–$185,000 per year plus benefits. Quidel Ortho offers comprehensive compensation and growth opportunities.

The Senior Regulatory Affairs Manager, IVD & Medical Devices position in the Legal, Management & Operations field is open for applications.

We aim to respond to suitable candidates as soon as possible.

Full responsibilities and requirements are described in the listing above.

Learn more about the Senior Regulatory Affairs Manager, IVD & Medical Devices role in the description above.

We appreciate your interest in this position.

Position Requirements
10+ Years work experience
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