Regulatory Affairs Manager

Regulatory Affairs Manager focuses on leading regulatory compliance for class i wound‑care medical devices across uk and eu markets.

What the role involves

• Leading regulatory compliance for Class I wound‑care medical devices across UK and EU markets.
• Maintain all Technical Files, ensuring alignment with UK and EU requirements and ISO 13485 requirements.
• Update Declarations of Conformity, UKCA/CE marking processes, and product registrations.
• Monitoring regulatory changes and proactively update internal stakeholders on new requirements affecting product lines.
• 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.

Skills and requirements

• Minimum 5 years’ regulatory experience within the medical device industry, specifically with UK/EU Class I devices.
• Strong working knowledge of ISO 13485.
• Must be able to work 100% on‑site near Watford.
• Experience within wound care or similar product categories.

Confirmed role details

• · Job Type: Full-Time, permanent role.