Regulatory Compliance Lead

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 :

• Manage, operate and maintain ISO 9001, ISO 14001 and ISO
  13485 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…