Job search

Compliance Manager (CMM786)

Overview

Reference
CMM786

Salary
£/annum

Job Location
- United Kingdom -- England -- South East England -- Surrey -- Leatherhead

Job Type
Permanent

Posted
22 April 2021


Compliance Manager – Competitive – Leatherhead, Surrey

The Role

Do you have at least 5 years’ experience of managing and maintaining a company’s Quality Management System, alongside good knowledge of the UK healthcare industry?

If so, Docobo, a market-leader in telehealth services, are looking for a Compliance Manager to be the company’s appointed manager for quality and regulatory affairs.

The key responsibilities of a Compliance Manager include, but are not limited to:

  • Maintain certification in all areas.
  • Undertake internal audits and host external audits.
  • Maintain the associated technical files.
  • Ensure regular collection of evidence for the annual Clinical Evaluation and Post Market Surveillance Reports.
  • Maintain a knowledge of the changing regulatory standards and implement the changes necessary.
  • Deliver the supporting QA/RA documentation required for sales Frameworks and Tender responses.
  • Maintaining security, integrity, and confidentiality of data.

The Company

Docobo is a UK Digital Health company developing and supplying Population Health Intelligence and Remote Monitoring solutions to enable intelligence-led care and support for citizens in their own homes, improving the quality of life for patients, carers and clinicians.

We lead the market with an array of exciting hardware and software devices dedicated to delivering telehealth services within the digital healthcare market.

The Person

The key skills and qualities of a Compliance Manager are:

  • Good knowledge of the UK healthcare industry and UK and European medical device regulatory requirements.
  • A proven track record with at least 5 years’ experience of managing and maintaining a company’s Quality Management System.
  • A proven track record with at least 3 years’ experience of managing and maintaining ISO 27001.
  • Experience of transition to MDR, and the development and maintenance of electronic and software devices and technical Files under MDD.
  • To fulfil the above, you will require an up-to-date and working knowledge of the following:
    • MDD and MDR (Class 1 & 11a)
    • BS EN ISO 13485, 14971, 14155, 27001
    • BS EN IEC 60601
    • BS EN 62304
    • NHS DCB0129 / DCB0160
    • GDPR

If you are keen on joining this exciting, forward thinking company and taking the next step in your career, then please click the apply now button to find out more.


Contact information

Ivor Tarrant