Regulatory Affairs Strategist

4 days ago


Austin, Texas, United States Enovis Full time

About Us

Enovis is a leading medical technology company that transforms lives by creating innovative products and solutions. We are committed to delivering exceptional results and strive for excellence in everything we do.

Job Overview

We are seeking a skilled Regulatory Affairs Strategist to join our team. The successful candidate will work closely with our cross-functional teams to develop and implement regulatory strategies for new and modified medical devices.

Key Responsibilities

  • Develop and execute regulatory strategies for new and modified products, ensuring compliance with FDA and international regulations.
  • Collaborate with regulatory and cross-functional peers to resolve potential regulatory/technical issues and questions from regulatory agencies.
  • Manage the release and shipment of products under regulatory controls to all regions.
  • Provide recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the importance of regulatory requirements.
  • Coordinate and prepare regulatory submissions for new and modified products, ensuring compliance with applicable regulatory requirements and company policies.

Requirements

  • Bachelor's degree with a minimum of 2 years of medical device industry experience.
  • Prior experience with regulatory submissions, such as PMA or 510(k).
  • Working knowledge of FDA and international regulations for medical devices.
  • General understanding of the product development process and design controls.

Benefits

  • Competitive salary: $120,000 - $150,000 per year.
  • Medical, dental, and vision insurance.
  • 401(k) plan with company match.
  • Generous paid time off and holidays.

About Enovis

Enovis is an equal employment opportunity employer and welcomes applications from diverse candidates. We strive to create a workplace that is inclusive and respectful of all employees. We are committed to providing a safe and healthy work environment and adhere to all applicable laws and regulations.

EOE AA M/F/VET/Disability Statement



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