Regulatory Affairs Manager - Medical Devices - IVDD - Quality
Permanent
Remote with 2 days a month in the office which is based in Central London
Salary up to £58,000 Flex depending on experience
The Regulatory Affairs Manager is an important role for our client, responsible for establishing regulatory compliance, to ensure they are operating within guidelines and managing documents efficiently.
In this position you will be both inward looking (working diligently to assure compliance, support all Quality Management System related activities as directed by the Head of QIRA and the regulatory QA approver (pre/post release of products), and also outward looking (monitoring the regulatory landscape, keeping the Head of QIRA updated on Regulatory strategy changes and keeping our client well governed in the face of change).
Skills and Experience for Success
We anticipate the ideal candidate will have:
· Expert knowledge of the medical device regulations IVDD and desirable IVDR and MDR
· Demonstrable understanding of harmonised ISO standards
· Proven ability in drafting and updating technical documentation and to prepare comprehensive and actionable reports on time
· Familiarity with clinical research and the NHS (National Health Service).
· Good understanding of the elements of a Quality Management System
· Proven expertise in planning and conducting audits and writing audit reports
· Good understanding of the nonconformity/CAPA process
· Up to date knowledge of the relevant ISO standards and regulatory requirements
Desirable Experience
· Proven experience with working with Software as a Medical Device (SAMD)
Qualifications
· Bachelor's degree in a technical or related field
· Auditor qualification or experience in auditing
· Regulatory experience in the industry
Due to the high volume of applications, we receive we are not able to get back to everyone who applies. Therefore, if you have not heard back from Experis within 7 days please assume that your application has been unsuccessful however we will contact you if suitable roles come up that match your skill set.
