Are you an experienced Quality & Regulatory professional in the Medical Device sector looking to take ownership of compliance, QMS management, and global regulatory submissions?
We are seeking a proactive and detail-driven Quality & Regulatory Officer to lead and maintain compliance across UK, EU and international markets. This is a key role supporting Medical Device regulatory strategy, Quality Management Systems (QMS), technical documentation, post-market surveillance, and audit readiness.
This role will take ownership of the Quality Management System (QMS) and ensure compliance with EU MDR, FDA 21 CFR Part 820, ISO 13485, UKCA and global regulatory requirements. You will manage Technical Files, support regulatory submissions (CE, 510(k), Health Canada), lead audits, oversee CAPA and vigilance activities, and provide regulatory support for new product development.
Key Responsibilities:
- Maintain and improve ISO 13485 compliant QMS
- Manage Notified Body & internal audits
- Compile and maintain Technical Documentation
- Oversee post-market surveillance & risk management (ISO 14971)
- Support global product registrations
- Review labelling, IFUs & regulatory documentation
About You:
- Proven experience in Medical Device Quality & Regulatory Affairs
- Strong knowledge of MDR, FDA, ISO 13485
- Audit and Technical File management experience
- Detail-oriented with strong organisational skills
The role requires working on side in the company's offices 3 days a week.
This is an excellent opportunity to play a key role in maintaining regulatory compliance and supporting international market growth within the MedTech sector.