The THOMAS Recruitment Group are recruiting on behalf of a Medical Company who are looking to recruit a Junior Compliance Officer on a permanent basis.
Position Summary
Support Regulatory compliance to all market requirements. Ensure our client’s continued compliance to relevant regulations and standards. Support global registration activity to facilitate Company expansion.
Main duties
* Assist in maintenance of Technical Files, including creation and control of documentation.
* Control and revision of documentation through electronic document control system(s).
* Support transition from Medical Device Directive (93/42/EEC) to Medical Device Regulation (2017/745) where required.
* Liaise with all departments to support Regulatory department activities.
* Implement actions as directed by Regulatory Managers, including in support of Engineering Changes.
* Support Quality, Regulatory and Technical during external and internal audits.
* Support in global registration activities.
Essential
* Degree (or equivalent) in a scientific or engineering field
* Capability of working independently as well as within a multi-disciplinary team environment.
* Excellent communication skills both orally and written.
* Strong collaborative skills
* Proficiency in document manipulation using various software packages including, but not limited to, Microsoft Word, Excel, Power Point and Adobe
Desirable
* Understanding of regulatory requirements for medical devices including Medical Device Directive (MDD) 93/94/EEC, ISO 13485 and ISO 14971
* Awareness of Medical Device Regulation (MDR) 2017/745
* Awareness of Design Controls as per 21 CFR Part 820.30, and requirements for Design History Files
* Medical Device registration experience
The THOMAS Recruitment Group are an Employment Business. We supply temporary, contract and permanent staff to various companies throughout the UK to various sectors.
Located in South Wales, Midlands & the South West, we recruit for temporary and permanent job roles across the following core areas:
INDUSTRIAL | DRIVING | FMCG | PROFESSIONAL | ONSITE
If you are interested in this position, then please click ‘APPLY NOW’ below
