Senior Regulatory Affairs Director

4 weeks ago


Reston, Virginia, United States The Mullings Group Full time
Senior Regulatory Affairs Leader Opportunity

We are seeking a seasoned Senior Regulatory Affairs Leader to spearhead our client's FDA Pre-Market Approval submission activities for a revolutionary new robotic-assisted transcatheter valve replacement platform.

Key Responsibilities:

  • Lead all FDA Pre-Market Approval submission activities, including post-market supplements and international product registrations
  • Collaborate with the FDA to ensure a successful PMA submission and approval
  • Develop and implement regulatory strategies to support the company's growth and innovation

Requirements:

  • Background in cardiovascular solutions or alternative medical implantables, robotics, and/or class III medical electronics
  • Proven experience with PMA approval and regulatory affairs leadership
  • Strong communication and collaboration skills

About The Mullings Group:

We are a trusted partner for medical device companies, providing expert regulatory affairs services to support their growth and success.



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