Regulatory Affairs Specialist

Job Title
Regulatory Affairs Specialist

Job Description

Job title:
Regulatory Affairs Specialist
The Regulatory Affairs Specialist provides regulatory guidance for business unit product lines. The Regulatory Affairs Specialist works directly with cross-functional teams to support global product market clearances.

Your role:

Regulatory Affairs representative for business unit Programs and assists with regulatory matters such as labeling, marketing, technical documents, and regulatory design change assessment required in the Development Life Cycle

Support the cross-functional teams with regulatory guidance during all design control phases of a new product, major and/or minor changes

Directly responsible for the coordination and preparation of document packages to support global submissions and regulatory activities, including US, EU and Canada [510(k) Pre-market Notifications, PMAs, Product Reports/Supplements, GUDID (UDI), Technical Files, Declarations of Conformity, International Medical Device Licenses

Guide global compliance, such as CE Marking and product registrations, clinical evaluations, Canada Medical Device Regulations, etc

Support in external audits (e.g., FDA, CFDA, KFDA, PMDA, Notified Bodies) for Regulatory Affairs matters

Serves as local regulatory interface between the markets and the BIU site

Serves as local regulatory interface for the global business RA team

Maintains Product Shipment Authorization for business unit product lines based on completion of localization and licensing.

You're the right fit if you have:

Relevant academic degree, B.Sc. in engineering and/or life science is preferable

Knowledge of the relevant global regulations for successful preparation and submission of 510(k), PMA, TF and international registrations worldwide

Ability to communicate effectively with cross-functional teams

Excellent English skills (written and oral)

M.Sc. - an advantage

Certified regulatory affairs professional- an advantage

About Philips
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

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