Regulatory Affairs Manager - Wound Care in Luton

Cpl Life Sciences is partnering with a small but growing medical device organisation that specialises in innovative wound care solutions designed to improve healing outcomes and patient quality of life. With an expanding product portfolio and a commitment to quality, safety, and regulatory excellence, the business is seeking an experienced Regulatory Manager to lead and strengthen regulatory operations.

As the Regulatory Manager, you will take ownership of all regulatory activities for a range of Class I medical devices, ensuring full compliance with UKCA, CE, and relevant UK MDR/ISO 13485 requirements. You will act as the key regulatory authority within the organisation, partnering closely with Quality, R&D, Operations, and external stakeholders to ensure timely approvals, compliant documentation, and smooth market access.

This position is ideal for a hands-on regulatory professional who thrives in a small but growing organisation. You will be responsible for anything regulatory-related and will be the face of the function.

• Regulatory Strategy & Compliance
  • Lead regulatory compliance for Class I wound-care medical devices across UK and EU markets.
  • Manage and maintain all Technical Files, ensuring alignment with UK and EU requirements and ISO 13485 requirements.
  • Oversee and update Declarations of Conformity, UKCA/CE marking processes, and product registrations.
  • Monitor regulatory changes and proactively update internal stakeholders on new requirements affecting product lines.
• Documentation & Quality Interface
  • Ensure all regulatory documentation meets current standards, including risk management files, clinical evaluations (where applicable), PMS documentation, and labelling.
  • Work closely with the Quality team to maintain a compliant ISO 13485 Quality Management System.
  • Support internal and external audits, acting as the regulatory point of contact.
• Cross-Functional Collaboration
  • Provide regulatory guidance to R&D, Operations, and Commercial teams during product development, change control, and lifecycle management.
  • Review and approve labelling, artwork, IFUs, packaging, and promotional materials for compliance.
  • Liaise with suppliers, notified bodies and regulatory agencies as required.
• Post-Market Responsibilities
  • Support Post-Market Surveillance activities, including vigilance reporting and trending.
  • Ensure timely assessment and documentation of product changes, field actions, and regulatory updates.

• Essential Requirements
  • Minimum 5 years’ regulatory experience within the medical device industry, specifically with UK/EU Class I devices.
  • Proven expertise in CE marking, UKCA requirements, and building/maintaining technical documentation.
  • Strong working knowledge of ISO 13485.
  • Experience collaborating with cross-functional teams in a manufacturing or R&D environment.
  • Excellent attention to detail, strong communication skills, and ability to manage multiple projects.
  • Must be able to work 100% on-site near Watford.
• Desirable
  • Experience within wound care or similar product categories.
  • Exposure to higher-class devices or notified body interactions.
  • Understanding of risk management (ISO 14971).

• Opportunity to take full ownership of the regulatory function within a growing business.
• Close-knit team environment with genuine influence over product and compliance direction.
• Competitive salary and benefits package.
• Career growth as the business scales and expands regulatory operations.

Please note this role does not offer job sponsorship and you MUST hold the full right to work in the UK now and in the future without any restrictions. As mentioned above this role is 100% on site and you must live in a commutable distance.