Quality and Regulatory Affairs Manager

Position

Position: Quality Assurance & Regulatory Affairs Manager / Director

Location: Middlesex, West London, Surrey

Please note:

• You MUST be able to work in the office 5 days per week through your probationary period
• You MUST have medical devices sector experience in the UK
• You MUST have the right to work in the UK without restriction

Base pay range

This range is provided by Nicholas Associates. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Purpose of the Role

To lead UK quality and regulatory strategy, ensuring compliance across the company's product portfolio. This role is pivotal in enabling market access, maintaining high standards, and embedding quality throughout the product lifecycle.

Strategic Leadership

• Represent role model or servant leader model leadership as a member of senior site management team.
• Develop and implement the QARA strategy aligned with business goals and regulatory compliance requirements.
• Collaborate with Engineering, Operations, and Commercial teams to integrate quality and compliance from concept to delivery.
• Represent the company in regulatory compliance audits and external engagements.

Regulatory Affairs

• Oversee global product registrations and submissions, including CE marking and international approvals for company products
• Support in defining regulatory pathways early in product development, including Intended Use and Risk Classification.
• Ensure compliance with ISO 13485, MDR, FDA 21 CFR Part 820, and other relevant standards.

Quality Assurance

• Maintain and enhance the Quality Management System (QMS).
• Lead internal and supplier audits, investigations, and corrective actions.
• Analyse QA data to drive continuous improvement and risk mitigation.

Project Oversight

• Lead QARA team in managing regulatory documentation and audit readiness.
• Support change control and post-market surveillance activities.

Team Development

• Mentor and develop QARA team members.
• Ensure training programmes reflect current regulatory and quality practices.

Skills & Experience

• Proven leadership in QARA within medical devices or regulated industries.
• Experience with CE marking, Medical Device Requirements, both EU and UK, regulatory submissions, electrical safety requirements, software validation, and international compliance.
• Excellent communication and stakeholder engagement skills.
• Familiarity with electronic QMS and project management tools.

Desirable Qualifications

• Degree in Engineering, Life Sciences, or related field (Master’s preferred).
• Experience working directly with regulatory bodies.
• Lead Auditor Certification

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Quality Assurance and Management
• Industries: Medical Equipment Manufacturing and Manufacturing

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