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Role Filled

Quality Assurance / Regulatory Affairs Manager

Medical Devices & Equipment
Regulatory & Compliance
Medical Devices
Kent
£Speak to Graham

Role Overview

Are you an experienced Quality Control Manager / Specialist, with a strong medical device background? If so, Zenopa has the role for you.

TITLE – Quality Assurance / (QARA) Regulatory Affairs Manager Manager
PRODUCTS – Dental / Medical Devices
LOCATION – Kent

In this exciting QARA Management role, you will take be an integral part of the Operations team and will organise, plan, direct and control all Regulatory Affairs and Quality Management functions including product registration, complaint handling & reporting, internal and external quality audits. You will also serves as the Quality System Management Representative and Medical Device person responsible for Regulatory Affairs and will develop policies, procedures and training to ensure efficient operation of the company quality system and regulatory requirements.

Requirements
1. Degree educated or equivalent, in a life science or engineering discipline
2. A minimum of 5 years’ experience in a medical device regulatory environment
3. An in-depth knowledge and appreciation of the regulatory requirements including technical files for placing class I & II medical devices on the European market. Experience in other markets (North America, Asia-Pacific markets) would be desirable.
4. Strong Knowledge of the Medical Device Directive (MDD) and Medical Device Regulations (MDR)

Apply now to find out more about this exciting role.

Locations

Ashford
Banstead
Beckenham
Bexley
Brighton
Bromley
Canterbury
Carshalton
Caterham
Chertsey
Chessington
Crawley
Croydon
Dartford
Eastbourne
Epsom
Gatwick
Gravesend
Haywards Heath
Herne Bay
Horsham
Hove
Kingston-upon-Thames
Leatherhead
Lewes
Maidstone
Margate
Medway
Mitcham
Morden
Orpington
Purley
Redhill
Sevenoaks
Sidcup
Sutton
Tonbridge
Tunbridge Wells
Whitstable
Previous Listing
Date Updated
28 Sep 2023
Job reference
69970
Categories
Full Time
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