Director Global Regulatory Affairs

Director Global Regulatory Affairs - (MEDICAL DEVICE - 25% travel) - US Based Candidates

Our client is a leading medical device company focused on developing innovative solutions to improve patient outcomes. We are looking for a highly experienced Director Global Regulatory Affairs to join our client’s team (experience with SaMD or AIML products is a bonus)

The Director Global Regulatory Affairs will be responsible for leading the regulatory affairs team and developing regulatory strategies for their medical devices and SaMD products. The successful candidate will have experience leading and being hands on with 510k submissions and developing outside of US regulatory strategies.

Responsibilities:

• Lead the regulatory affairs team and provide strategic direction for regulatory activities

• Develop and implement regulatory strategies for medical devices and SaMD products

• Lead the preparation and submission of 510k submissions

• Interact directly with regulatory bodies for the purpose of driving submissions to approval, as well as handling any post market issues.

• Build strong relationships with regulatory agencies and other stakeholders

• Stay up to date with changes in regulations and advise the company accordingly

• Ensure timely and accurate completion of regulatory submissions

Requirements:

• Experience working with SaMD is preferred

• Minimum of 10 years of experience in Regulatory Affairs in the Medical Device industry

• Strong knowledge of US and international regulations for medical devices

• Experience developing outside of US regulatory strategies

• Excellent communication, leadership, and organizational skills

• Ability to work independently and in a team

• Ability to manage multiple projects and prioritize tasks

This Director Global Regulatory Affairs position will require 25% travel to their manufacturing site in Massachusetts.

If you would like to learn more about this opportunity, apply today or contact me directly on the following:

wjlynch@barringtonjames.com