Regulatory Compliance Officer

UK Health Security Agency; Highgate; On-site; GBP 25,000 - 35,000; Full time

Job summary

A regulatory organization in the UK is seeking an entry-level role in regulatory affairs within the medical devices sector. This position involves ensuring compliance with medical device regulations, supporting audits, and maintaining quality management systems. The ideal candidate will contribute to regulatory compliance and play a key role in promoting patient safety. This is an excellent opportunity for professional growth and collaboration with a dedicated team in a unique regulatory environment.

Qualifications

• Strong understanding of UK MDR, EU IVDR/MDR, ISO 13485, and ISO 15189 regulations.
• Experience in regulatory compliance in the medical devices sector.
• Ability to manage documentation and coordinate compliance activities.

Responsibilities

• Ensure products meet medical device and quality regulations.
• Support audits and post-market activities.
• Maintain and enhance SOPs and compliance systems.

Job description

Are you looking to begin your career in regulatory affairs within the medical devices sector? Do you want to play a key role in ensuring patient safety and maintaining compliance with evolving regulatory standards? Have you considered joining a dynamic team that offers excellent opportunities for professional growth and development? If so, this could be the opportunity you’ve been seeking.

We have an exciting opening to join the Regulatory Assurance Compliance Unit (RACU) team, contributing to regulatory compliance and product oversight. This is a unique chance to be part of a forward‑thinking organization advancing its regulatory capabilities to support the procurement and/or manufacture of safe, effective medical devices—including in‑vitro diagnostics (IVDs) and software as medical devices (SaMD).

UKHSA is a legal manufacturer and a distributor of medical devices (MDs), including in‑vitro diagnostics (IVDs), software as medical device (SaMD), and related accessories. These devices fall under two main categories: 1) Commercial MDs/IVDs: intended for market distribution and requiring full regulatory compliance. 2) In‑house IVDs: used exclusively on UKHSA premises under the Health Institution Exemption (MHRA guidance). UKHSA maintains a robust and compliant Quality Management System (QMS) to support these functions.

Responsibilities

• Ensure UKHSA products meet all relevant medical device and quality regulations (UK MDR, EU IVDR/MDR, ISO 13485, ISO 15189).
• Support audits, inspections, and post‑market activities, ensuring continuous quality improvement and regulatory readiness.
• Maintain and enhance SOPs, QMS documentation, and compliance systems across development, manufacturing, and distribution.
• Provide regulatory and quality guidance to internal teams and projects, promoting best practice and compliance awareness.
• Manage documentation, reporting, and coordination activities to support effective governance and operational delivery.

This role is based within the RACU team and offers the opportunity to collaborate with colleagues across the wider organisation. Working alongside a highly motivated and dedicated team, you will be responsible for managing compliance activities and contributing to regulatory intelligence and strategy. Reporting to the team’s Scientific/Regulatory advisor, you will build and maintain strong relationships with stakeholders to ensure all regulatory requirements are met efficiently and effectively.

Equality and Inclusion

We pride ourselves as an employer of choice, where Everyone Matters, promoting equality of opportunity and actively encouraging applications from everyone, including groups currently underrepresented in our workforce. UKHSA’s ethos is to be an inclusive organisation for all our staff and stakeholders. We celebrate and protect differences by removing barriers and promoting equity and equality of opportunity for all.