Senior Regulatory Affairs Specialist
US RemoteRemote (US)senior$83K – $104K
via Greenhouse
About this role
POSITION SUMMARY: The Sr. Regulatory Affairs Specialist is responsible for the preparation of regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements as well as the objectives of the business. PRIMARY RESPONSIBILITIES: Understands and interprets U.S. and EU and international medical device and in vitro diagnostic device (IVD) regulatory requirements. Provides guidance on requirements to product development teams.…
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reqspace match rubricFive dimensions, recruiter-grade. Upload your resume and we'll generate a written explanation of where you fit and where the gaps are.
1
Skills match
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2
Level fit
This role is senior-level. We check your trajectory against it.
3
Domain experience
Your work in the role's domain matters more than your years total. We weight recent and direct experience.
4
Recency
A skill you used last quarter weighs more than one from five years ago. We grade on recency, not lifetime.
5
Location fit
This role is remote-eligible. We factor in your stated location and time-zone overlap.
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