Global QARA Director: Lead Quality & Regulatory Strategy

Metric Bio; Greater London; Hybrid; GBP 75,000 - 100,000; Full time

Benefits offered by this job

Collaborative and supportive work culture

Opportunity to influence innovative medical devices

Job summary

A leading medical technology firm in Surrey is seeking a Director of Quality Assurance and Regulatory Affairs to shape the regulatory strategy and ensure compliance within a diverse medical device portfolio. The ideal candidate will have proven leadership experience in quality assurance and regulatory affairs, knowledge of international compliance, and a strong engineering or life sciences background. This full-time role offers a collaborative and innovative work environment.

Qualifications

• Proven leadership in QARA within medical devices or regulated industries.
• Experience with CE marking, EU/UK MDR, regulatory submissions.
• Skilled in stakeholder engagement and communication.

Responsibilities

• Shape and implement QARA strategy as part of senior management.
• Oversee global product registrations and maintain compliance.
• Manage and improve QMS; lead audits and CAPAs.

Skills

Proven leadership in QARA within medical devices or regulated industries

Experience with CE marking, EU/UK MDR, regulatory submissions

Skilled in stakeholder engagement and communication

Familiarity with eQMS and project management tools

Degree in Engineering, Life Sciences, or related

Experience liaising directly with regulatory bodies

Lead Auditor certification

Education

Degree in Engineering, Life Sciences, or related

Master's preferred

Job description

A leading medical technology firm in Surrey is seeking a Director of Quality Assurance and Regulatory Affairs to shape the regulatory strategy and ensure compliance within a diverse medical device portfolio. The ideal candidate will have proven leadership experience in quality assurance and regulatory affairs, knowledge of international compliance, and a strong engineering or life sciences background. This full-time role offers a collaborative and innovative work environment.