Apsida Life Science are currently partnered with a highly innovative and established medical device company in the US who specialise in new therapies and devices to improve the outcome of those with cancer. They are seeking a Senior Regulatory Affairs Specialist to join the team, due to being in a rapid growth phase. The organisation offer brilliant career progression opportunities, hybrid working (3 days on-site, down to you which 3 days you choose) and flexible working hours.

Responsibilities:

• Prepare and file regulatory submissions for countries such as US FDA (510(k), PMA etc.), Europe, Canada and other international markets.
• Work cross-functionally with other departments to keep them abreast of regulatory changes, trends and best practices.
• Drive the timely registration of new products whilst maintaining the existing product portfolio.
• Participate in audits and inspections.
• Support post-market compliance activities.

Requirements:

• Bachelor's degree in Life Science.
• 4 year's experience in Regulatory Affairs - Medical Device.
• Experience with Class II (IIa / IIb) and/or III devices minimum. Class I device experience ONLY is not sufficient enough.
• Has led at least part of a submission themselves, e.g. led and authored a 510(k) submission.
• Self-starter mentality, working independently whilst also being a team-player.

If you are interested in learning more, please reach out to Geneva Jones at Apsida Life Science:

[email protected]

www.apsida.co.uk

+44 (0) 203 854 2418

Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK) & Boston (USA) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost effective, high quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.