Apsida Life Science are currently partnered with an actively growing, novel start-up medical device organisation who have designed a personalised AI-driven device to help treat serious respiratory illnesses. Following recent funding, they are seeking a seasoned professional - a (Senior) Regulatory Affairs Manager - to join the team.
Responsibilities:
* Manage and implement regulatory strategies for compliance with EU MDR and FDA clearance (De Novo).
* Create and maintain the regulatory roadmap and documentation for EU & US submissions.
* Lead the interactions with regulatory authorities for the company's SaMD.
* Contribute to clinical evaluation activities (CEP/CER and post-market surveillance).
Requirements:
* Life Science focused degree.
* Minimum 5 years' experience in Regulatory Affairs for medical devices.
* Experience in SaMD (software products) is a huge preference.
* Proven success with FDA clearances (De Novo/510(k)), and EU MDR certification.
* Must be hands-on, independent and a self-starter.
If you are interested in learning more, please reach out to Geneva Jones at Apsida Life Science:
Geneva.jones@apsida.com
www.apsida.co.uk
+44 (0) 7441341762 (Direct mobile)
+44 (0) 203 854 2418 (Direct landline)
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.