Healthcare Regulatory & Compliance Associate

Healthium Clinics; Henley-on-Thames; On-site; GBP 32,000 - 38,000; Full time

Benefits offered by this job

BUPA

Pension

Staff discount at company clinics

Golf

Gym vouchers

21 days holiday, rising by 1 day each

Birthday day off

Job summary

Healthium Clinics is seeking a Regulatory Affairs Associate / Compliance Officer to join our team in Henley-on-Thames. The role focuses on turning complex regulatory requirements into practical actions across governance, clinical services and lifecycle documentation.

You will connect clinical, technical and commercial teams to ensure patient safety, data protection and confidential handling of information while supporting audits, tenders and market access.

Qualifications

• Essential: Relevant degree or professional qualification in regulatory affairs, quality assurance, healthcare, life sciences, clinical research or related discipline.
• Essential: Experience in healthcare, clinical research, medical devices or digital health, including preparing, reviewing or maintaining regulated documentation.
• Essential: Experience with policies, SOPs, risk assessments or quality records, and solid document-control knowledge.
• Essential: Ability to interpret regulatory, contractual and procedural requirements and turn gaps into practical actions.
• Essential: Experience coordinating evidence across teams while managing priorities.
• Essential: Understanding of data protection, confidentiality and compliance records.
• Essential: Strong organisational, analytical and communication skills with careful escalation.

Responsibilities

• Translate procurement and client requirements into evidence checklists and deadlines, and coordinate evidence packs.
• Support the Quality Management System, including policies, SOPs, templates and quality records.
• Maintain medical-device regulatory and technical documentation, registrations and lifecycle evidence.
• Support governance, inspections, and readiness for new clinical services and projects.
• Maintain risk assessments and registers, and track corrective or improvement actions.
• Maintain controls for confidential information and coordinate data-protection and cybersecurity evidence.
• Summarise regulatory guidance from MHRA, CQC, NHS, NICE and ICO and support changes.
• Liaise with regulators, commissioners, clients, manufacturers and consultants.

Skills

Regulatory affairs

Quality assurance

Document control

Regulatory interpretation

Project coordination

Data protection

Organisational skills

Analytical skills

Communication skills

Education

Relevant degree or professional qualification

Job description

Healthium Clinics is seeking a Regulatory Affairs Associate / Compliance Officer to join our team in Henley-on-Thames. The role focuses on turning complex regulatory requirements into practical actions across governance, clinical services and lifecycle documentation.

You will connect clinical, technical and commercial teams to ensure patient safety, data protection and confidential handling of information while supporting audits, tenders and market access.