Regulatory Affairs Manager - Manchester - £50-60k - IVD, MedDev

Recruiter
Meet Recruitment Ltd
Location
Manchester
Salary
£50-60k
Posted
18 Mar 2017
Closes
17 Apr 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
This is a newly created position and will report directly in to the Regulatory Affairs Director. The dynamic Diagnostics company are based in Manchester. The perfect candidate will be an established Regulatory Manager that has previously been hands on with a small to medium team previously with a proven history of success in Regulatory Affairs from within the Medical Device or IVD industry.

RA Manager, £50-60k, Manchester, IVDs, Medical Device

Please contact Nathan Berkley on ************* or email ****************************** if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

General Responsibilities:

- Lead a team of Regulatory & Quality Specialists
* The creation, management and maintenance of Technical Files for Class I, IIa and IIb Medical Devices
* Management of ISO 13485 & ISO 9001 Quality Management System
* Efficacy data & Stability data
* Design history and design development
* Conducting external and Internal audits across client sites
* Assistance for other RA Executives - Technical file data for dossiers

Skills Required:

- At least 5 years Medical Device experience
* Solid experience within Regulatory affairs
* Line Management Experience
* Experience in Biocides Directive
* Experience of the MDD 93/42/EEC with experience of Technical file building and submissions under this Directive (Essential)
* Understanding of cosmetic / Personal Care regulatory affairs is desirable
* BSc (or equivalent) in Science

Please contact Nathan Berkley on ************* or email ****************************** if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

Meet are good people who are great at recruitment. We're proud to partner with the industry's leading Pharmaceutical, Biotechnology, Medical Device, Marketing Communications and Contract Research Organisations (CROs) worldwide, helping them to find and secure the best global talent available. We pride ourselves on our open, friendly approach and are here to guide you through the recruitment process every step of the way.

Find out more about us at *************************** and **********************************-berkley-a25811139/

Key Words

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