Regulatory Affairs Specialist - Risk in Oxford

Halianis currently recruitingfor an experienced Reg affairs Risk Management specialist for a manufacturing client in theCotsworlds.

Location: UK (multi-site flexibility)
Industry: Medical Devices
Employment Type: Full-time, Permanent

A leading UK-based medical device manufacturer is seeking an experienced Risk Management Specialist to join its Quality & Regulatory team. This is an excellent opportunity to play a pivotal role in ensuring product safety, regulatory compliance, and successful product launches within a highly regulated environment.

The Opportunity

This role offers the chance to take ownership of risk management activities across the full product lifecycle from R&D and new product introduction through to post-market surveillance of established products.

Working cross-functionally with R&D, Production, Human Factors and Regulatory teams, you will act as the subject matter expert for risk management, ensuring all documentation and processes remain compliant with global regulatory requirements.

This is a highly visible position requiring strong influencing skills and the confidence to challenge where appropriate.

Key Responsibilities

• Lead risk management activities for new product development projects.

• Maintain and update Risk Management Files for on-market medical devices.

• Ensure compliance with relevant medical device regulations and standards.

• Integrate complaint data, adverse events and post-market surveillance outputs into risk documentation.

• Support updates following design, process, or regulatory changes.

• Drive timely closure of risk-related actions with key stakeholders.

• Contribute to KPI reporting and continuous improvement initiatives.

Candidate Profile

We are looking for a quality professional with strong experience in medical device risk management and regulatory compliance.

Essential Experience:

• Minimum 5 years experience in medical device quality roles.

• Hands-on experience preparing and maintaining Risk Management Files.

• Strong understanding of complaint handling and post-market surveillance requirements (EU knowledge essential).

• Working knowledge of relevant risk management and medical device regulations.

• Experience in technical documentation and report writing.

• Strong stakeholder engagement and influencing skills.

Qualifications:

• A-Level (or equivalent) or relevant industry experience.

Personal Attributes

• Highly organised and detail-focused

• Confident communicator across all business levels

• Proactive, resilient and solution-oriented

• Comfortable working in a cross-functional, regulated environment

Whats on Offer

• Competitive salary (dependent on experience)

• Opportunity to join an established, growing medical device organisation

• Exposure to innovative product development projects

• Collaborative and quality-driven culture

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