Senior Quality & Regulatory Specialist (Medical Devices)

GBUK Group; Bicester; On-site; GBP 40,000 - 55,000; Full time

Job summary

A leading provider of medical devices is seeking a Senior Quality & Regulatory Associate to support Quality and Regulatory activities in Bicester. The role involves developing processes that meet standards, conducting audits, and managing non-conformities. Essential qualifications include experience in the medical device industry, familiarity with ISO standards, and auditing experience. Join a growing organization where your contributions impact patient care and device safety.

Benefits

Professional development opportunities

Cross-functional collaboration

Meaningful contribution to patient care

Qualifications

• Experience in a Quality environment within the Medical Device industry.
• Minimum experience with recognised QMS: ISO 13485 or ISO 9001.
• Lead Auditor level experience in internal auditing.

Responsibilities

• Develop and implement processes meeting standards and regulations.
• Plan and complete internal and external supplier audits.
• Prepare documentation for and assist with external audits.

Skills

Quality control experience

Knowledge of ISO 13485 or ISO 9001

Internal auditing experience

CAPA and Root Cause Analysis

Process writing compliance

Job description

A leading provider of medical devices is seeking a Senior Quality & Regulatory Associate to support Quality and Regulatory activities in Bicester. The role involves developing processes that meet standards, conducting audits, and managing non-conformities. Essential qualifications include experience in the medical device industry, familiarity with ISO standards, and auditing experience. Join a growing organization where your contributions impact patient care and device safety.