Head of Regulatory Affairs North America

Overview

The Head of Regulatory Affairs North America oversees the regulatory activities for the North American region, interfacing with local government regulatory bodies, the FDA, foreign registrars, and regulatory groups as required for product registrations and compliance requirements.

Success Profile

A successful candidate should have 12+ years of experience in a Medical Device manufacturing company, with 5+ years in a senior managerial/director level role. They should have a Bachelor’s Degree in Mechanical or Electrical Engineering or Life Science, with an advanced degree preferred. The candidate must have a working knowledge of the U.S. Food Drug and Cosmetic Act, FDA medical device product approval processes, and Quality Systems Regulations. Technical knowledge of Medical Devices used in dialysis and renal care is also required. Leadership ability, strong interpersonal skills, and the ability to manage multiple tasks are essential.

Rewards

The position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave, and potential for performance-based bonuses depending on company and individual performance.

Connect

Fresenius Medical Care is an equal opportunity employer and maintains a drug-free workplace. The rate of pay for this position will depend on the successful candidate's work location and qualifications, including relevant education, work experience, skills, and competencies. The position is available in multiple locations.