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Medical Devices Regulatory Affairs & Quality Assurance Manager

United States   •  Negotiable  •  Permanent, Full time


Medical Devices Regulatory Affairs and Quality Assurance Manager - Boston

A growing Medical Devices company, based in Boston, are currently looking for a Regulatory Affairs and Quality Assurance Manager to help lead their RA and QA duties across the business.

As the company grows, you will likely hire a team to work around you but to start with you will be actively working on the Regulatory Affairs and Quality Assurance documentation and submissions yourself, rather than current managing people who do the documentation accumulation and submissions for you.

Ideally, you will have been working for a company where you focused on a new Medical Device that has come to market. This could have been for a start-up or scale-up company or within a larger organisation where you have had sole responsibility on a new Medical Device.

Specific knowledge of FDA 510k Submission is essential. You may have been responsible for putting the submission together for a more senior person actually submitted as the skillset in putting the information together is more important.

This is a growing Medical Devices company who have invented an industry disrupting medical device that will take market share from a number of the larger companies across the globe, meaning future company growth is likely and you'll gain opportunities to take on more responsibility and develop your career.

Ideally, you will have worked on the RA & QA duties for a handheld Medical Device, however this is not essential if you have worked on a larger Medical Technology. It is essential for you to have worked on Medical Devices, we cannot have someone transferring from another sector for this role as you will be the RA/QA specialist at the business.

If you are interested in this role, make an application straight away. The company will move quickly for the right person, so if you hold off making an application they may move ahead with another candidate.

For more information, please feel free to call Andrew Welsh, Director of Medical Devices recruitment and Scientific recruitment specialists Newton Colmore Consulting, on +44 121 268 2240 or make an application and one of our team at Newton Colmore Consulting will contact you.

Newton Colmore Consulting is a specialist recruitment company within the Medical Devices, Scientific Engineering, Scientific Software, Robotics, Data Science, Healthcare Communications. Science, Electronics Design, New Product Design, Human Factors, Regulatory Affairs, Quality Assurance and Field Service Engineering sectors.


You MUST be eligible to work in United States. Learn more

  • Agency: Newton Colmore Consulting
  • Reference: MDRAaQAMB01
  • Posted: 1st September 2021
  • Expires: 29th September 2021

Newton Colmore Consulting

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