Job Description
Halianis currently recruitingfor an experienced Reg affairs Risk Management specialist for a manufacturing client in theCotsworlds.
Location: UK (multi-site flexibility)Industry: Medical DevicesEmployment 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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