Senior Quality & Regulatory Affairs Specialist
Company: confidential
- Location: Burgess Hill, United Kingdom
- Seniority: Senior
- Employment type: Part-time
- Posted: 10 days ago
- Offer language: English
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.
Skills & Experience Needed:
- 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.
To apply for this role, please call and/or send your CV to David Hopkin.
