Company: Clinical Professionals Ltd
Closing Date: 05 Jan 17
Type: Full Time
Salary (£): On Application
Benefits: Up to £60k + Benefits
Regulatory Affairs & Risk Manager - Medical Devices. Warwickshire. Our client is a medical device developer of complex (software/electronic) portable patient monitoring systems, they are a developing company who are creating jobs, due to further growth
Regulatory Affairs & Risk Manager - Medical Devices
Our client is a medical device developer of complex (software/electronic) portable patient monitoring systems, they are a developing company who are creating jobs, due to further growth, they are now looking to secure the services of a Regulatory Affairs and Risk Manager to join their team of development experts in Warwickshire.
Up to £60,000 per annum plus benefits - candidates seeking more or less will also be considered
Warwickshire - commutable from Stratford upon Avon, Leamington Spa, Worcester, Alcester, Cheltenham, Coventry, Birmingham, Kidderminster, Redditch, Rugby, Banbury, Solihull, Bromsgrove
RA & Risk Manager
Reporting to the RA/QA Director, the main focus of this role is to develop regulatory affairs strategy and maintain regulatory compliance. Key responsibilities include:
-Drive vigilance processes as required for US, Europe and further relevant markets
-Vigilance & clinical evaluation reporting
-Define regulatory pathways for entry to global markets
-Provide risk assurance support to design and development teams
-Provide team leadership for regulatory affairs team members
-Strong understanding of regulatory standards including MDD (93/42EEC), ISO 13485, ISO 14971, IEC 60601, IEC 62366, IEC 62304 - ideally
-Experience of ISO 14971
-Experience with complex devices - required
-Experience working in risk management
-Excellent communication and presentation skills
-Experience operating at strategic level
This is an excellent opportunity to work in a regulatory and risk focused position within a growing medical device developer. If you have RA experience working on complex medical devices and are seeking a position in the Warwickshire area, please apply today.
Clinical Professionals is a leading life science staffing business with recent award in staffing innovation. Our dedicated Medical Device Team focus on finding positions within regulatory affairs, quality assurance, clinical research and sales.
Pems, 13485, electronic, electronics, software, monitoring, remote monitoring, reg, ra, risk, regulatory affairs, risk, risk manager,
Clinical Professionals UK
33 Blagrave Street
|Tel:||0044 118 959 4990|
|Fax:||0044 118 956 0607|
|Website:||Visit Our Web Site|
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