Regulatory Affairs Associate​/Compliance Officer

Bring regulatory rigour to an ambitious healthcare environment where innovation, patient care and high standards go hand in hand. This opportunity suits someone who enjoys turning complex requirements into clear, practical compliance.

If you’ve also worked in the following roles, we’d also like to hear from you:
Quality and Compliance Officer, Regulatory Compliance Officer, Compliance Associate, Quality Assurance Officer, Regulatory Affairs Officer, Quality and Compliance Associate, Governance and Compliance Officer, Regulatory Coordinator

SALARY: starting at £35,000 per annum + Benefits

LOCATION:

Henley-on-Thames, Oxfordshire

JOB TYPE:
Full-Time, Permanent

This is an opportunity to help shape how high standards, innovation and safe patient care come together across varied healthcare and technology activity.

As a Regulatory Affairs Associate / Compliance Officer you’ll support market access, quality systems and governance, working collaboratively with clinical, technical and commercial colleagues.

The Regulatory Affairs Associate / Compliance Officer will help keep evidence, registrations and controls ready for scrutiny while supporting practical progress. In this Regulatory Affairs Associate / Compliance Officer position, careful judgement, curiosity and clear communication will matter just as much as strong documentation.

Healthium Clinics is a private medical clinic specialising in the latest anti-aging and medical treatments designed to improve your health and wellbeing. Based in the elegant Badgemore Park, our luxurious treatment rooms have ample private parking and a discrete entrance, with appointments to suit your busy schedule. Our experienced and qualified medically led team work closely with you to achieve great results.

• Market Access and Tenders:
  Translate procurement, commissioner and client requirements into evidence checklists, actions, owners and deadlines, and coordinate compliant evidence packs
• Quality Management System:
  Support the development and maintenance of the Quality Management System, including policies, SOPs, Work Instructions, forms, templates and quality records
• Regulatory and Technical Documentation:
  Monitor applicable requirements and prepare, coordinate and maintain medical-device regulatory and technical documentation, registrations and lifecycle evidence
• Clinical Governance and CQC:
  Support healthcare governance, CQC compliance, inspections, reviews and readiness for new clinical services and projects
• Risk Management and Audits:
  Maintain risk assessments and registers, support internal and external audits, record findings and track corrective or improvement actions
• Information Governance and Security:
  Maintain appropriate controls for confidential information and coordinate data-protection, information-governance and cybersecurity evidence
• Regulatory Monitoring:
  Review relevant developments and guidance from bodies including the MHRA, CQC, NHS organisations, NICE and ICO, summarising implications and supporting agreed changes
• Records and Stakeholder Liaison:
  Maintain accurate controlled compliance records and liaise professionally with regulators, commissioners, clients, manufacturers, suppliers and consultants

• Relevant degree, professional qualification or equivalent experience in regulatory affairs, quality assurance, healthcare, life sciences, clinical research or a related discipline
• Previous experience within healthcare, clinical research, medical devices or digital health, including preparing, reviewing or maintaining regulated documentation
• Experience working with policies, SOPs, Work Instructions, risk assessments or quality records and maintaining…