Quality & Regulatory Affairs Leader - Medical Devices UK

Nicholas Associates; Walton-on-Thames; On-site; GBP 85,000 - 115,000; Full time

Job summary

A healthcare compliance firm is seeking a Quality Assurance & Regulatory Affairs Manager/Director to lead UK compliance strategy. Key responsibilities include overseeing product registrations, ensuring ISO compliance, and mentoring the QARA team. The ideal candidate has proven leadership in medical devices, strong communication skills, and experience with regulatory submissions. This full-time role requires presence in the office five days a week.

Qualifications

• Proven leadership in QARA within medical devices or regulated industries.
• Experience with CE marking and regulatory submissions.
• Excellent communication skills.

Responsibilities

• Lead UK quality and regulatory strategy for compliance.
• Collaborate with teams for quality integration in product lifecycle.
• Oversee global product registrations and submissions.

Skills

Leadership in QARA

Communication and stakeholder engagement

Experience with regulatory submissions

Familiarity with electronic QMS

Education

Degree in Engineering, Life Sciences, or related field

Job description

A healthcare compliance firm is seeking a Quality Assurance & Regulatory Affairs Manager/Director to lead UK compliance strategy. Key responsibilities include overseeing product registrations, ensuring ISO compliance, and mentoring the QARA team. The ideal candidate has proven leadership in medical devices, strong communication skills, and experience with regulatory submissions. This full-time role requires presence in the office five days a week.