The Company:
We're partnering with an innovative medical device company based just outside London. They're strengthening their Regulatory Affairs & Quality Assurance team to support in global growth and commitment to compliance, safety, and quality.
The Role:
We are seeking a motivated and detail-oriented Regulatory Affairs Associate to join our clients regulatory team. Reporting to the Regulatory Affairs Manager, you will play a key role in supporting global regulatory submissions, maintaining compliance documentation, and ensuring adherence to regulatory standards for medical devices in the EU, US, and other markets.
Key Responsibilities:
* Assist in the preparation and submission of regulatory documentation for CE marking under MDR and FDA 510(k) submissions.
* Support the development and maintenance of Technical Files and Design Dossiers.
* Contribute to risk management activities in line with ISO 14971.
* Monitor and interpret regulatory requirements, and provide guidance to internal teams.
* Work closely with R&D, Quality, and Manufacturing teams to ensure regulatory compliance throughout the product lifecycle.
* Maintain regulatory documentation and records in line with internal procedures and external requirements.
* Support internal and external audits as needed.
About You
* 18 months to 2 years’ experience in a Regulatory Affairs role within the medical device industry.
* Exposure to CE marking processes under the EU MDR and FDA regulatory submissions.
* Solid understanding of risk management principles and regulatory standards (e.g., ISO 14971, ISO 13485).
* Degree in life sciences, engineering, or a related technical field.
* Strong attention to detail and a compliance-driven mindset.
* Excellent written and verbal communication skills.
* Able to work independently and collaboratively within a cross-functional team.
* Comfortable with a full-time, on-site role at UK headquarters.
Interested in this position? Apply now !
✉ caustin@barringtonjames.com
☎ +44 (0) 1293 776644