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Director of Regulatory Affairs

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Location
MN
Job Type
Direct Hire
Date
Jan 11, 2019
Job ID
2650221
Our mid-sized medical device client is adding a Director of Regulatory Affairs to the team. The Director will have 7 direct reports with one being OUS. The RA team currently reports to the VP RA/CL/QA and because of growth, they are adding a Director.  Bring your experience in the medical device industry with you to explore this fascinating company, be part of the integration, and play a role in these trail-blazing opportunities. Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.


The Director of Regulatory Affairs will identify, review, and anticipate emerging regulatory device issues. This individual will perform a gap analysis and ensure all applicable device regulations are met by the current product. The Director will develop and implement regulatory strategies and guidance based on U.S. and international requirements as defined in FDA Regulations for combination products, ISO 13485:2003 Standard, European Medical Device Directives and other pertinent International Regulations. This role also will establish effective dialogue with U.S. and international regulatory authorities, direct the planning and preparation of device regulatory submissions for the company’s product, and facilitate timely product registrations and regulatory approvals.


Desired Profile:

  • B.S. degree in Engineering, Chemistry or related discipline
  • 10+ years of regulatory experience in a medical regulatory environment (PMA and combo preferred)
  • 5+ years of management experience
  • Knowledge of Regulatory requirements for devices and/or pharmaceutical credentials
  • Comprehensive technical skills/knowledge
  • Advanced problem-solving skills
  • High attention to details
  • Up to 20% travel