Healthcare Regulatory Affairs & Compliance Specialist

Healthium Clinics; Lower Assendon; On-site; GBP 32,000 - 39,000; Full time

Benefits offered by this job

BUPA

Pension

Staff discount at clinics

Golf

Gym vouchers

21 days' holiday, rising to 25 + bank

Birthday day off

Job summary

Healthium Clinics seeks a Regulatory Affairs Associate / Compliance Officer to bring regulatory rigour to a healthcare environment blending innovation and patient care. You will support market access, quality systems and governance across clinical, technical and commercial teams.

The role involves maintaining evidence, registrations and controls for scrutiny, with clear communication and careful judgement as essential attributes.

Qualifications

• Regulatory affairs, quality assurance in healthcare, life sciences knowledge.
• Experience maintaining regulated documentation and quality records.
• Familiarity with risk assessments, SOPs and policy documents.
• Experience coordinating evidence across departments and managing multiple workstreams.
• Knowledge of MHRA device registration and lifecycle documentation.
• Audits and inspections support experience.

Responsibilities

• Market Access and regulatory evidence coordination across teams.
• Support development and maintenance of Quality Management System and records.
• Prepare and maintain regulatory/technical documentation and registrations.
• Support governance, CQC compliance, inspections and readiness for new services.
• Maintain risk assessments and support internal/external audits and actions.
• Manage information governance, data protection and cybersecurity evidence.
• Monitor MHRA/NHS/NICE guidance and summarise implications.
• Maintain controlled compliance records and liaise with regulators and clients.

Skills

Regulatory affairs knowledge

Quality management

Audits & compliance

Documentation control

Cross-functional collaboration

Education

Relevant degree or professional qualification

Job description

Healthium Clinics seeks a Regulatory Affairs Associate / Compliance Officer to bring regulatory rigour to a healthcare environment blending innovation and patient care. You will support market access, quality systems and governance across clinical, technical and commercial teams.

The role involves maintaining evidence, registrations and controls for scrutiny, with clear communication and careful judgement as essential attributes.