Regulatory Affairs Specialist - Risk

Halian

is currently recruiting

for an experienced Reg affairs Risk Management specialist for a manufacturing client in the

Cotsworlds

.

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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