Compliance and Governance Expert

2 months ago


Bracknell, Bracknell Forest, United Kingdom HealthHero Group Full time

As a Quality and Compliance Manager at HealthHero Group, you will play a vital role in ensuring the highest standards of product quality, compliance, and governance across our organization.

Our Clinical Product Team is responsible for developing and delivering innovative digital-first healthcare solutions that connect patients with gold-standard clinical expertise. We operate in the UK, Ireland, France, and Germany, with a mission to simplify healthcare and improve lives.

In this exciting role, you will:

  • Provide expert guidance on product quality, compliance, and governance to various departments and areas.
  • Work closely with our medical device teams to ensure compliance with relevant regulations and standards.
  • Manage the quality and compliance of the entire product lifecycle, from design to delivery.

You will be responsible for chairing meetings and committees, leading the transition of Class 1 Medical Devices to Class 2a under the EU MDR framework, and preparing for ISO13485 audits. You will also ensure compliance with clinical risk management standards, provide information on reported quality and safety issues, and audit key systems.

The estimated salary for this role is £65,000 - £80,000 per annum, depending on experience. To succeed, you should possess knowledge and experience in quality management and medical device governance within an ISO 13485 accredited healthcare organization. Desirable experience with software as a medical device, including MDR submissions, is also beneficial.

As a valued member of our team, you can expect a range of benefits, including a company pension scheme, access to HealthHero healthcare services, and a generous holiday package. If you are passionate about quality and compliance, we encourage you to apply for this exciting opportunity



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