Regulatory Compliance Lead

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

Job summary

A leading supplier of medical devices in the UK is seeking a Regulatory Compliance Lead to ensure adherence to ISO standards and manage compliance systems. The role involves coordinating with various departments for product conformity and supporting regulatory inspections. This permanent position offers a competitive salary of £45,000 annually, along with a profit share bonus and additional benefits including flexible working hours, parking, and a pension scheme.

Benefits

Profit share bonus

Flexible working hours

Free lunch

Parking

Pension plan

23 days annual leave + bank holidays

Qualifications

• Experience managing ISO 9001, ISO 14001, and ISO 13485.
• Proficiency in CE and MDR compliance.
• Ability to coordinate with multiple departments for product compliance.

Responsibilities

• Manage and maintain compliance systems.
• Compile regulatory documentation in response to inquiries.
• Support regulatory inspections and audits.

Skills

Regulatory documentation submission

ISO 9001 knowledge

Experience with CE and MDR

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…