Part-Time Medical Device QA & Regulatory Lead (Class I)

L-ev8 Recruitment Ltd; Burgess Hill; Hybride; GBP 45 000 - 55 000; Temps partiel

Résumé du poste

West Sussex based medical device organisation is seeking a Senior Quality & Regulatory Affairs Specialist on a part-time basis (2.5 days per week). The role focuses on maintaining quality and regulatory compliance for a Class I(s) medical device, with outsourced manufacturing, and involves supplier oversight, documentation, audits and post-market surveillance.

Candidates should have 5+ years in QA/Regulatory Affairs for medical devices, with ISO 13485 knowledge and UK/EU regulatory exposure.

Qualifications

• Minimum 5 years' experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
• Working knowledge of ISO 13485 and UK/EU medical device regulatory requirements.
• Experience overseeing contract manufacturers and critical suppliers.
• Experience reviewing validation, qualification and change control documentation.
• Experience maintaining technical files, technical documentation and declarations of conformity.
• Knowledge of complaint handling, vigilance and post-market surveillance activities.
• Previous experience supporting or acting as a PRRC would be desirable.
• Experience with Class I or Class I(s) medical devices would be beneficial.

Responsabilités

• Maintain the quality and regulatory compliance of an established Class I(s) medical device.
• Oversee supplier quality and compliance and review batch documentation.
• Support validation, qualification and change control activities.
• Maintain technical documentation and declarations of conformity.
• Support audits and post-market surveillance.

Connaissances

Quality Assurance

Regulatory Affairs

Medical devices

PRRC awareness

Description du poste

West Sussex based medical device organisation is seeking a Senior Quality & Regulatory Affairs Specialist on a part-time basis (2.5 days per week). The role focuses on maintaining quality and regulatory compliance for a Class I(s) medical device, with outsourced manufacturing, and involves supplier oversight, documentation, audits and post-market surveillance.

Candidates should have 5+ years in QA/Regulatory Affairs for medical devices, with ISO 13485 knowledge and UK/EU regulatory exposure.