Invent Staffing · 1 day ago

Regulatory Affairs Consultant

United States

Contract

Remote

Senior Level

5+ years exp

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Responsibilities

Prepare and manage regulatory submissions, including PMA supplements for the US market and EU MDR technical documentation changes for the EU market, ensuring compliance with the latest regulatory requirements.

Offer regulatory expertise for Class III sterilization products within the cardiac rhythm management portfolio, ensuring products meet both US FDA and EU MDR standards.

Work collaboratively with cross-functional teams, including R&D, quality, and manufacturing, to ensure regulatory requirements are met throughout the product lifecycle.

Ensure compliance with US FDA and EU MDR regulations by managing regulatory submissions, amendments, and maintaining up-to-date technical documentation.

Oversee and support product registrations, submissions, and amendments across both US and EU regions.

Keep abreast of regulatory changes and assess the impact of these developments on ongoing and future projects, ensuring that regulatory strategies are updated as needed.

Provide input during product development and change management processes, offering strategic regulatory guidance to meet market requirements.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory AffairsClass III Medical DevicesPMA ProcessesEU MDR ComplianceSterilization ProductsRegulatory DocumentationRegulatory ComplianceCombination ProductsCross-functional Collaboration

Required

At least 5 years of experience in regulatory affairs within the medical device industry, specifically with Class III products in the US and EU markets.

Proven experience with Class III medical devices, particularly focusing on regulatory compliance in both US FDA (PMA) and EU MDR (technical documentation).

Experience working with sterilization products in the cardiac rhythm management space.

Strong knowledge of PMA processes in the US and EU MDR requirements, with the ability to interpret and apply regulatory standards.

Driver’s License (DL Copy)

Visa Copy (if applicable)

2 Professional References