Quality Assurance & Compliance Manager Digital Health

Charing Cross Station
07 Nov 2017
15 Nov 2017
Contract Type
Full Time
Real Staffing are partnering an exceptionally successful, rapidly growing Artificial Intelligence Healthcare focused technology and product organisation who have won numerous awards recognising their rapid growth, technology and for leading in their field since their inception to find a handson Quality Assurance & Compliance Manager to be based in London.

They are a team on a mission, to put accessible and affordable healthcare in the hands of every person on earth. Their mission is bold and ambitious, and its one thats shared by their team who epitomise our values, to dream big, build fast and be brilliant.

To achieve this, theyve brought together one of the largest teams of scientists, clinicians, mathematicians and engineers to focus on combining the ever growing computing power of machines, with the best medical expertise of humans, to create a comprehensive, immediate and personalised health service and make it universally available.

Key responsibilities:

Own the ISO, MHRA, FDA and NHS quality and security processes, and in doing so maintain the associated certifications that relate to them
Manage the ongoing internal audit schedules, and the required rectification plans for any nonconformances discovered
Find ways to continually improve the companys processes through engagement with the senior/executive leadship team
Ensure the company stays up to date with changes to standards and key regulations
Be a Subject Matter Expert and point of contact for the teams when a question around process, security and/or risk is raised
Act as a conduit with the Clinical teams where their regulatory requirements overlaps with the wider business (and vice versa).

Required Experience:

Demonstrable background in Quality Assurance positions
In depth knowledge of MHRA, ISO 13485 and ISO 27001 standards with the capability to work and shape standards authorities policy
A background in Healthcare/Life Sciences/Pharmaceutical/Medical Devices/Digital Health

Desirable Experience:

MSc or PhD in relative field
Understanding of international standards including the FDA (21 CFR 820 etc) and IEC 62304
Experience working for a regulatory or notified body.
Indepth Cybersecurity experience
Relevant Quality related Qualifications or memberships

If this opportunity aligns with your career aspirations please get in contact with Lillie FenlonBillson at Real Staffing on l.fenlonbillson at ######.### or ##### ######Sthree UK is acting as an Employment Agency in relation to this vacancy. Advertised through Zoek 51caad31fa1f4e0e847603d1566dea0412