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Regulatory Affairs Specialist

2 months ago

Austin, Texas, United States Enovis Full time
Job Title: Regulatory Affairs Specialist

At Enovis, we are seeking a skilled and experienced Regulatory Affairs Specialist to join our team. The successful candidate will work closely with our product development teams to ensure compliance with regulatory requirements and bring new and modified medical devices to market.

Key Responsibilities:
  • Develop and execute regulatory strategies for new and modified products.
  • Work 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.
  • Review and approve design and manufacturing changes for existing products, ensuring compliance with applicable regulations.
  • Provide technical guidance and regulatory training to cross-functional teams.
  • Review device labeling and advertising materials for compliance with applicable regulations and recommend appropriate changes.
  • Monitor the development of new regulatory requirements and advise of the impact to cross-functional teams.
  • Develop and maintain procedures to ensure compliance and support business goals.
  • Maintain proficiency in government regulations and guidances.
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.
  • Ability to manage several projects simultaneously.
  • Strong interpersonal and influencing skills.
  • Ability to independently manage projects, prioritize time and communicate effectively.
Work Environment:

Ability to sit and stand for long periods of time.

Enovis is an equal employment opportunity employer and welcomes applications from diverse candidates. We offer a comprehensive benefits package, including medical insurance, dental insurance, vision insurance, spending and savings accounts, 401(k) plan, vacation, sick leave, and holidays.