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Job Details

Regulatory Affairs & Risk Manager - Medical Devices

Company: Clinical Professionals Ltd
Location: Warwickshire
Reference: J25140
Closing Date: 09 Apr 17
Type: Full Time
Salary (£): On Application
Benefits: Up to £60k + Benefits

Job Summary:

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
Medical Devices

Warwickshire - commutable from Stratford upon Avon, Leamington Spa, Worcester, Alcester, Cheltenham, Coventry, Birmingham, Kidderminster, Redditch, Rugby, Banbury, Solihull, Bromsgrove

RA & Risk Manager

Key responsibilities:
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
Experience required:
-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.

Job reference:
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,

Apply for this job: Regulatory Affairs & Risk Manager - Medical Devices

Contact Information:

Address:  Clinical Professionals UK
3rd Floor
33 Blagrave Street
Tel:  0044 118 959 4990
Fax:  0044 118 956 0607
Website:  Visit Our Web Site

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