Part-Time Senior Medical Device Quality & Regulatory Specialist

Adelphi Group; Haywards Heath; Hybride; GBP 50 000 - 70 000; Temps partiel

Avantages offerts par ce poste

EV salary sacrifice car option

Pension Plan contributions

Résumé du poste

Adelphi Group is seeking a Senior quality & regulatory affairs specialist for on-site work in Haywards Heath to support day-to-day oversight of the quality management system and regulatory activities. The role will share PRRC responsibilities with the Head of Quality and focus on ensuring continued compliance for a mature medical device portfolio.

You will manage technical documentation, support regulatory submissions, and collaborate with contract manufacturers and suppliers to uphold UK/EU MDR

Qualifications

• 5+ years in Quality Assurance and/or Regulatory Affairs in medical devices.
• Working knowledge of ISO 13485 and UK/EU medical device regulations.
• Experience overseeing contract manufacturers and critical suppliers.
• Experience reviewing validation, qualification, and change-control documentation.

Responsabilités

• Oversee quality and regulatory compliance for device and outsourced manufacturing.
• Review batch documentation, COAs, certificates and quality records.
• Maintain awareness of UK MDR, EU MDR, ISO 13485 and related guidance.
• Support PRRC responsibilities and maintain technical documentation.
• Assist with regulatory submissions, declarations, and registrations as required.
• Support internal and external audits and management reviews.

Connaissances

Quality Assurance

Regulatory Affairs

Independent worker

Documentation

Description du poste

Adelphi Group is seeking a Senior quality & regulatory affairs specialist for on-site work in Haywards Heath to support day-to-day oversight of the quality management system and regulatory activities. The role will share PRRC responsibilities with the Head of Quality and focus on ensuring continued compliance for a mature medical device portfolio.

You will manage technical documentation, support regulatory submissions, and collaborate with contract manufacturers and suppliers to uphold UK/EU MDR