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.
Overview
A leading supplier of medical devices and consumables is 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.
Key Responsibilities – Regulatory & Quality Compliance
- Manage, operate and maintain ISO 9001, ISO 14001 and ISO 13485 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 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
- Maintain and update 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.
Qualifications 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.
Benefits
- Salary £45,000 per annum.
- 40 hours per week 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.
- Modern office Environment.
Please apply for this role through the job board or apply directly. For further information, please call Adam on (phone number removed).