Philips Senior Regulatory Affairs Specialist 

United States, Minnesota 

922328711

Senior Regulatory Affairs Specialist

In this role you

The Senior Regulatory Specialist will provide regulatory support for our Image Guided Therapy business including direct submission to health authorities and indirect project management of worldwide registrations. You will execute regulatory strategy to support the growth within the Structural Heart/Heart Rhythm Management category

Your role:

• Preparing comprehensive regulatory strategies for potentially complex new devices, and significant post market changes (such as line extensions, indication expansions, and substantive process/design changes). As necessary, reviews complex regulatory strategy issues with RA management.
• Preparing regulatory filings for the US, EU, and Canada, potentially including FDA Pre-Submissions (and similar) for new products, as well as post-market changes. Maintain proficiency in worldwide regulatory requirements, particularly within US, EU, Canada, Japan, and China.
• Following Philips' Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP, and all other applicable regulations.
• Able to professionally negotiate and lead meetings (eg Pre-Subs) directly with regulatory agencies (e.g. FDA, Notified Bodies, etc.) on regulatory filings at the reviewer or management (eg Chief or Deputy) level.

You're the right fit if:

• Minimum of a bachelor’s degree in engineering or a related scientific field. Degree within Regulatory Affairs and/or Regulatory Affairs Certification is preferred.
• Minimum of 5+ years of experience in the medical device industry with regulatory submission experience. 510(k) submission experience. Prefer 2+ years of experience with SaMD.
• Proficiency in understanding, interpretation and application of FDA 21 CFR 820 Quality System Regulation, EU MDR Regulation 2017/745, ISO 13485, and other relevant standards and regulations.
• Prior experience supporting/leading regulatory submissions such as 510(k), EU MDR Technical Documentation and global registrations
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

How we work together

This is an office role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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The pay range for this position in Plymouth is $75,000 to $130,000, Annually.

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US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

within commuting distance to Plymouth, MN.