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Job Details

Regulatory Affairs & Risk Manager - Medical Devices

Company: Clinical Professionals Ltd
Location: Warwickshire
Reference: J25140
Closing Date: 05 Jan 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

Requirements:

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, they are now looking to secure the services of a Regulatory Affairs and Risk Manager to join their team of development experts in Warwickshire.

Salary:
Up to £60,000 per annum plus benefits - candidates seeking more or less will also be considered
Sector:
Medical Devices

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

Position:
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

Summary:
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:
J25140
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.
Keywords:
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
Reading
Berkshire
RG1 1PW
England
Tel:  0044 118 959 4990
Fax:  0044 118 956 0607
Website:  Visit Our Web Site

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