Senior Regulatory Affairs Director

2 months ago


California, United States The Mullings Group Full time

Job Summary

The Mullings Group is seeking a highly skilled Senior Regulatory Affairs Leader to spearhead all FDA Pre-Market Approval submission activities as well as post-market supplements and international product registrations for our client, a transformational new medtech start-up utilizing advanced robotics to combat structural heart disease.

About the Role

This is a critical component toward our client's future operations, leading the organization through its upcoming IDE award, and fostering a clear and collaborative communication line with the FDA to ensure a successful PMA submission and approval.

Key Responsibilities

  • Develop and implement regulatory strategies to ensure compliance with FDA regulations and guidelines
  • Lead the preparation and submission of FDA Pre-Market Approval applications and post-market supplements
  • Collaborate with cross-functional teams to ensure regulatory requirements are met throughout the product development lifecycle
  • Establish and maintain relationships with FDA regulatory personnel to ensure a successful PMA submission and approval
  • Stay up-to-date with FDA regulations and guidelines, and provide guidance to the team on regulatory requirements

Requirements

We are seeking a background in cardiovascular solutions, however open to alternative medical implantables, robotics, and/or class III medical electronics with prior successful PMA approval.

What We Offer

The Mullings Group is a leading recruitment agency specializing in the placement of top talent in the medtech industry. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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