Senior Quality & Regulatory Affairs Specialist

Adelphi Group; Haywards Heath; Hybrid; GBP 50,000 - 70,000; Part time

Benefits offered by this job

EV salary sacrifice car option

Pension Plan contributions

Job summary

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.

Responsibilities

• 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.

Skills

Quality Assurance

Regulatory Affairs

Independent worker

Documentation

Job description

Senior quality & regulatory affairs specialist (medical devices & PRRC)

Location: Haywards Heath, West Sussex (On-Site)
Reporting to: Head of Quality

The Company

At The Adelphi Group of Companies we are proud of the products and the high level of services we provide to our customers and understand the importance of our philanthropic activities to give back to the community. We have been a privately owned family organisation for over 75 years, over which time we have acquired multiple businesses and exponentially expanded our product portfolio both domestically and internationally. Our focus is manufacturing and distributing packaging equipment and components, predominately in the highly regulated arena of pharmaceuticals, biotech, diagnostics and sterile products, with expertise in additional market sectors of cosmetics, food & beverage, household products, and lube oil.

Adelphi Healthcare Packaging is a trusted global distributor of high-quality primary packaging solutions serving the pharmaceutical and healthcare industries globally.

We are also the legal manufacturer of a long-established Class I(s) medical device that has been successfully marketed for over 30 years. Manufacturing operations are fully outsourced to an approved contract manufacturer, with AHP maintaining responsibility for regulatory compliance, product quality, and legal manufacturer obligations.

We are seeking an experienced Quality and Regulatory professional to provide day-to-day oversight of the medical device quality and regulatory system, support ongoing compliance activities, and share Person Responsible for Regulatory Compliance (PRRC) responsibilities with the Head of Quality.

The Role

This is a specialist part-time role focused on maintaining compliance for a mature and established medical device. The successful candidate will work closely with the Head of Qualityto ensure that AHP continues to fulfil its obligations as the legal manufacturer under applicable UK and EU medical device regulations.

The role will serve as a key point of contact for quality and regulatory activities relating to the device and outsourced manufacturing arrangements and will share responsibility for PRRC activities, ensuring continued compliance with applicable regulatory requirements.

Key Resposibilities

Quality & Compliance Oversight

• Maintain oversight of the contract manufacturer's quality and compliance performance.
• Review batch documentation, Certificates of Conformity, Certificates of Analysis, and associated quality records.
• Review validation, revalidation, and qualification activities undertaken by external manufacturers and suppliers.
• Assess and approve quality-related changes impacting the device, manufacturing processes, materials, or suppliers.
• Support supplier qualification, monitoring, performance review, and audit activities.
• Review and maintain Quality Agreements with external service providers and manufacturers.

Regulatory Activities

• Maintain awareness of developments in UK MDR, EU MDR, ISO 13485, and associated guidance documents and standards.
• Assess regulatory changes and advise on potential impacts to the business and product compliance.
• Support maintenance of technical documentation and regulatory records.
• Support management of complaints, vigilance activities, field actions, and post-market surveillance activities where applicable.

Assist with regulatory submissions, declarations, and registrations as required.

Shared PRRC Responsibilities

Working alongside the Head of Quality, the role will support and contribute to the responsibilities of the Person Responsible for Regulatory Compliance (PRRC), including:

• Verification that device conformity requirements have been appropriately assessed prior to product release.
• Maintenance of technical documentation and declarations of conformity.
• Oversight of post-market surveillance and vigilance activities.
• Review of quality and regulatory compliance activities relating to the outsourced manufacturer.
• Escalation of significant compliance issues and regulatory risks.
• Support for maintaining compliance with applicable UK and EU Medical Device Regulations.

Audit & Management System Support

• Support internal audits and external ISO 13485 audits.
• Participate in management review activities relating to the medical device quality management system.
• Identify opportunities for continuous improvement within quality and regulatory processes.
• Provide quality and regulatory support to the Head of Quality and wider business as required.

Candidate Profile

• Minimum 5 years' experience within Quality Assurance and/or Regulatory Affairs in 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.
• Strong understanding of quality management systems and compliance requirements.
• Ability to work independently and effectively manage a specialist compliance programme.

Excellent written communication and document review skills.

• Experience with Class I or Class I(s) medical devices.
• Experience supporting or acting as a PRRC.
• Internal Auditor or Lead Auditor qualification.
• Experience maintaining technical files and regulatory documentation.
• Experience supporting notified body or certification body audits.

What's on offer?

• EV salary sacrifice car option
• Pension Plan contributions

Adelphi is a family owned and managed business since its beginnings in 1947 and this will continueon tothe next generation. This continuity of ownership has promoted a stability that is valued by our suppliers, employees and customers alike. Many of our relationships date back over decades and are built on mutual respect and trust.

The Adelphi Group of Companies is an equal opportunity employer and values diversity.