Job Ref: 213387434

Date: 2021-03-18 11:57:47

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Regulatory Affairs Manager – Quality Assurance
Location: Home and Office Based (Stokenchurch), HP14 3SX
Salary: Competitive, DOE
Contract: 12m FTC / Full time
DEKRA Certification is a global product safety organisation. We are expanding services and have new opportunities in our UK office at DEKRA Certification UK Limited.
We have an exciting opportunity for an QA/RA Manager to join our growing Certification Team, which includes medical device ISO 9001, ISO 13485 and UKCA certification.
The successful candidate will be required to establish, implement and maintain the quality management and regulatory affairs processes for DEKRA Certification UK Ltd.
As our Regulatory Affairs Manager, you will be responsible for:
* Advise management about quality, improvement and accreditation matters
* Authorise processes and procedures
* Approve the internal audit planning
* Organise relevant input for Management review
* Assign tasks for control and develop the quality management system
* Organise maintenance of the quality management system
* Analyse the results of quality measurements based on KPI’s
* Support process improvements and advise on proposals for improvements
* Report to management and escalate in case of critical matters
In order to be successful in this role it is essential that you have:
* Regulatory affairs experience. Ideally on regulatory panels relevant to medical devices
* Quality Assurance experience within a notified body
* Strong leadership skills
* Attention to detail
* Excellent verbal and written communication skills
* Project management experience
* Degree educated – life science or engineering preferred
The candidate must be based in the UK.
If you feel you have the necessary skills and experience to be successful in this role click on “APPLY” today, forwarding an up-to-date copy of your CV for consideration in the first instance. We look forward to receiving your application.
No agencies please

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