Senior Quality & Regulatory Affairs Specialist

L-ev8 Recruitment Ltd; Burgess Hill; Hybrid; GBP 45,000 - 55,000; Part time

Job summary

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.

Responsibilities

• 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.

Skills

Quality Assurance

Regulatory Affairs

Medical devices

PRRC awareness

Job description

Senior Quality & Regulatory Affairs Specialist – West Sussex – Up to £50,000 pa (Pro-Rata) – REF 092

Up to £50,000 pa (Pro-Rata) + Benefits

Part-Time | 2.5 Days per Week

West Sussex

An excellent opportunity has arisen to join a long-established, privately owned international organisation specialising in packaging solutions for the pharmaceutical, healthcare, biotech and diagnostics sectors. With over 75 years of industry experience, the business is seeking an experienced Senior Quality & Regulatory Affairs Specialist on a part time basis to support medical device compliance, quality assurance and regulatory activities within its established healthcare packaging division.

Reporting directly to the Head of Quality, this specialist part-time role will focus on maintaining the quality and regulatory compliance of an established Class I(s) medical device, with manufacturing outsourced to an approved contract manufacturer. You will oversee supplier quality and compliance, review batch documentation, validation and change control activities, maintain technical documentation, and support audits and post-market surveillance.

• 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

This is an excellent opportunity for an experienced medical device quality and regulatory professional seeking a part-time position offering 2.5 days per week, with the opportunity to take ownership of specialist compliance activities and share PRRC responsibilities within an established international organisation. You will work closely with the Head of Quality, providing technical expertise and helping maintain the regulatory compliance of a mature, established medical device.