Quality Regulatory Assurance Lead

Overview

As Quality Regulatory Assurance Lead, you will steer day-to-day QA activities and guide a small team across registration, document control, training, product release, NCR/CAPA, and complaints processes. You will coordinate complaint handling and support investigations with operations and engineering, while aligning with the parent Quality Unit. You’ll maintain on-market regulatory compliance and drive the internal audit program, stay current with international standards, and support Health & Safety activities. This role offers impact in a mission-driven medical devices context within a flexible, collaborative environment.

Pay / Benefits

• Flexible start times
• Early finish on Fridays
• 25 days holiday + bank holidays
• Private health insurance
• Pension plan
• Life assurance

Responsibilities

• Manage day-to-day QA activities for registration, document control, training, product release, non-conformance and CAPA, and complaints processes
• Coordinate complaint handling activities and support investigations with operations and engineering and the parent Quality Unit
• Maintain ongoing regulatory compliance of products on the market
• Coordinate the internal audit program including scheduling, conducting audits, preparing reports, and progressing actions
• Stay aware of relevant international standards and regulatory guidance and update processes accordingly
• Support Health and Safety activities in line with the NBL Health and Safety Policy

Key requirements

• Degree in technical/engineering/science discipline or equivalent experience (5+ years in a similar role)
• Experience with internal audit techniques aligned to ISO 13485 (preferred)
• Analytical and problem-solving skills
• Strong attention to detail
• Experience in a regulated industry (medical devices or similar) in quality or technical roles
• Ability to prioritize workload and plan tasks to meet deadlines
• Excellent written and verbal communication skills; able to work independently and in a team

• Analytical thinking
• Problem-solving
• Attention to detail
• Internal audit techniques (ISO 13485)
• Regulatory compliance
• Documentation control

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