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⏰ Full-time

Head of Regulatory Affairs North America

Fresenius Medical Care
Location 📍 Waltham, United States
Posted 📅 June 23, 2026
Work Type ⏰ Full-time

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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Job Details

Employment Type
Full-time
📊
Category
other-general
🏠
Work Arrangement
On-site
📍
Location
Waltham, United States