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Head of Regulatory Affairs North America

Fresenius Medical Care | Waltham, United States | Posted July 04, 2026

Position Overview

PURPOSE AND SCOPE:
Interfaces with local government regulatory bodies, the FDA, foreign registrars, and regulatory groups as required for product registrations and compliance requirements. Directs and leads a staff of regulatory professionals and develops their expertise in the interpretation and application of appropriate regulations. Responds to FDA and district office requests, as deemed appropriate.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

+ Directs and controls the broad activities of Regulatory Affairs Devices through the interpretation, application, and implementation of company-wide policies and processes appropriate to the functional area.
+ Functions as a strategic leader with broad-based knowledge in individual department, and strong knowledge of industry practices and business principles. Works on complex issues and abstract issues/situations where analysis of situations or data requires an in-depth knowledge of the company.
+ Ensures that budget...

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