Regulatory Affairs Manager

Posted here is a great opportunity to be a part of a team who are leaders in the treatment of life threatening conditions!

A rapidly growing biotech/medical device client of X4 Life Sciences is looking for 2 Regulatory Affairs Managers to join their fast-paced organization. This is an exciting opportunity to join a company with a great mission and who are on a huge growth trajectory.

One manager (Major Markets) will focus on EU, US and Canada regulations and the other manager (International Markets) will focus on meeting international regulations. Both candidates must have full experience with PMA submissions (not just maintenance).

Responsibilities of this position include:

• Meeting US, EU, Canada & international regulatory requirements

• Submitting and authoring 510k submissions

• Liaising with Quality, R&D and Manufacturing on regulatory activities

• Overseeing the entire IDE and PMA submission process

Requirements:

• Successful 510k submission experience

• Experience with IDE and PMA's from start to finish (not just maintenance)

This is a small sized company offering competitive salary, benefits and working facilities. This position has the flexibility to be worked hybrid (on site periodically)

If your background aligns with the needs of this position, please apply to the job posting. If anyone in your network is a good fit please send across their details - we do offer a referral fee upon their successful placement!!