Regulatory Compliance Lead

Travail Employment Group; Newport; On-site; GBP 45,000; Full time

Job summary

A leading supplier of medical devices in Newport is seeking a Regulatory Compliance Lead to manage compliance with ISO standards and ensure CE and MDR regulations are met. The role involves compiling regulatory documentation, supporting audits, and maintaining product compliance through lifecycle coordination. The permanent position offers a salary of £45,000 per annum, flexible hours, a profit-share bonus, and additional benefits including lunch provision and pensions.

Benefits

Profit share bonus

Free Lunch provided

Parking

Pension

23 days + bank holidays annually

Qualifications

• Experience in managing ISO 9001, ISO 14001, and ISO 13485 systems.
• Strong understanding of CE and MDR regulations.
• Ability to compile and submit regulatory documentation.

Responsibilities

• Manage and maintain ISO compliance systems.
• Compile regulatory documentation per customer requests.
• Support regulatory audits and inspections.

Skills

Management of ISO systems

Understanding CE and MDR regulations

Regulatory documentation compilation

Knowledge of regulatory standards (MHRA, ISO)

Coordination with cross-functional teams

Experience in quality control systems

Job description

Job Description

Regulatory Compliance Lead

£45,000 per annum, Permanent role, 40 hours per week Monday to Friday, with flexible start and finish times within core hours, BS15 Bristol, profit share bonus, Free Lunch provided, parking and 23 days + bank holidays annually, pension.

A leading supplier of medical devices and consumables are currently seeking a regulatory compliance lead or quality and regulatory controller to join their expanding business. This long established business offers stability and long-term progression. Working closely with other departments, this role will see you involved in the following Key Responsibilities :

Regulatory & Quality Compliance

• Manage, operate and maintain ISO 9001, ISO 14001 and ISO13485 systems.
• Experience of managing CE and MDR (Medical Device Regulations)
• Compile and submit regulatory documentation in response to customer requests relating to compliance.
• Maintain up-to-date knowledge of regulatory standards (e.g., MHRA, ISO) and assist in strategic compliance decisions.
• Coordinate with R&D, Quality Assurance and Marketing to ensure product compliance throughout the lifecycle.
• Support regulatory inspections and audits, including documentation and corrective actions.
• Conduct monthly inspections of non-conforming goods with team members.
• Overall responsibility for QC System…