Regulatory Compliance Lead

linkup; Bristol; 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 oversee ISO management, regulatory documentation, and ensure compliance with healthcare standards. Candidates should have a degree in a relevant field and 5 years of experience in regulatory affairs or quality assurance. This role offers a salary of £45,000, flexible hours, profit share bonus, and additional benefits including free lunch, pension, and on-site parking.

Benefits

Free Lunch

Profit Share Bonus

23 days Holiday plus Bank Holidays

Pension

On site Parking

Qualifications

• 5 years' experience in regulatory affairs, quality assurance, or compliance.
• Strong understanding of international regulatory frameworks (e.g., ISO, MHRA, GDPR).
• Ability to manage multiple priorities and work independently.

Responsibilities

• Manage ISO 9001, ISO 14001 and ISO13485 systems.
• Compile and submit regulatory documentation.
• Conduct monthly inspections of non-conforming goods.

Skills

Regulatory affairs

Quality assurance

ISO compliance

Communication skills

Analytical skills

Education

Degree-level education in a relevant field

Tools

Document management systems

Microsoft Office

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 C E 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
• Overall responsibility for Health and Safety System Ethical and Legal Compliance
• Maintain and improve compliance, including management of the LSAS and MSAT assessments and the Modern Slavery Act.
• Serve as the Data Protection Officer, ensuring GDPR and data security compliance across the organisation.
• Complete and process DBS applications in coordination with Arcadia. Sustainability & Environmental Management
• Maintaining and updating the annual carbon reduction plan.
• Work toward a 42% recycling target during 2026.
• Identify and implement ongoing environmental improvements.
• Lead the organisation's B Corp Certification process - including initial set up, assessment, documentation, improvement planning, and submission.
• The successful regulatory compliance lead or quality & regulatory control person will have the following skills and experience :
• Degree-level education in a medical, scientific, regulatory, or related technical field.
• 5 years' experience in regulatory affairs, quality assurance, or compliance (preferably in healthcare, life sciences, or medical devices).
• Strong written and verbal communication skills.
• Familiarity with ISO 9001 / 14001 systems and ethical compliance standards.
• Solid understanding of international regulatory frameworks (e.g., ISO, MHRA, GDPR).
• Proficiency in document management systems and Microsoft Office.
• Strong analytical skills and attention to detail.
• Ability to manage multiple priorities and work independently.
• High ethical standards, accountability, and a solution-oriented mindset. This is an exciting opportunity to join a team orientated, stable and growing business which has resulted in this new role. As the person responsible for the regulatory compliance lead or quality and regulatory control person your contributions to the business will be valued and rewarded. Benefits include : regulatory compliance lead salary £45,000 per annum 40 hours with flexible start and finish times within core hours Free Lunch, daily Profit Share Bonus 23 days Holiday plus Bank Holidays, pension On site Parking with free electric car charging No bank holidays, No weekends Modern office Environment Please apply for this role through the job board or apply direct to or for further information, please call Adam on 0117 934 9770 Travail Employment Group Ltd is acting as an Employment Agency in relation to this vacancy.