Regulatory Affairs Associate

Omega Resource Group; Gloucester; Hybrid; GBP 35,000 - 50,000; Full time

Job summary

A global manufacturing business based in Gloucester seeks a Regulatory Affairs Associate to ensure compliance with international regulations. The successful candidate will manage associated technical documentation and collaborate across departments. The role requires proven experience in medical device regulatory functions and knowledge of relevant standards. Candidates should be detail-oriented and organized to thrive in a regulated environment.

Qualifications

• Proven experience in a medical device regulatory / quality role.
• Sound understanding of regulatory processes within medical device standards.
• Internal QMS auditing experience.

Responsibilities

• Ensure documentation aligns with ISO 13485, ISO 14971 and applicable IEC.
• Support preparation, review, and maintenance of technical documentation.
• Partner with various departments to ensure regulatory deliverables.

Skills

Regulatory compliance

Documentation management

ISO 13485 knowledge

Quality management systems

Ability to prioritize

Job description

Position: Regulatory Affairs Associate
Location: Gloucester
Job Type: Permanent / Onsite (Hybrid)

Our client, a global leading manufacturing business based in Gloucester, is seeking a detailed and organised Regulatory Affairs Associate to maintain regulatory compliance, obligations to international regulations and the organization of related technical documentation.

Role and Responsibilities

In this role, your key responsibility is to maintain regulatory compliance, obligations to international regulations and organization of related technical documentation.

• Ensure documentation aligns with ISO 13485, ISO 14971 and where applicable IEC.
• Support preparation, review, and maintenance of Technical Documentation, including device description, GSPR, risk management, clinical evaluation, PMS, PMCF, and labelling.
• Partner with R&I, Engineering, Quality, Manufacturing, Sales and Supply Chain to ensure regulatory deliverables are embedded and on time.
• Support international registrations (e.g., FDA listing support, Canada, Australia) as business needs evolve.

Experience or Qualifications

• Proven experience in a medical device regulatory / quality role.
• Sound understanding of regulatory processes within medical device standards (ISO 13485, MDR, FDA 21 CFR Part 280).
• Internal QMS auditing experience.
• Ability to prioritize and deliver to deadlines in a regulated environment.
• Candidates who currently are a Regulatory Affairs Associate, Regulatory Affairs Engineer, Regulatory Affairs Specialist or Quality & Regulatory Associate may be suitable for this position.

For more information regarding this Regulatory Affairs Associate role please contact Ben Herd.