Regulatory Specialist- Watford

1 day left

Austin Fraser
£42000 - £45000/annum
23 Jul 2017
22 Aug 2017
Contract Type
Full Time
Austin Fraser are currently working closely with a Medical Devices organisation who are seeking a Regulatory Affairs Specialist to be based at their offices in Watford.

Your responsibilities will be as follows:

All regulatory aspects of the CE marking process for the assigned medical devices with, emphasis on regulatory compliance and life cycle maintenance. In particular responsibility for devices of the Baxter Hospital Products Advanced Surgery Business.

All of the preparation and maintenance of registration files (e.g. STED/Technical Files) in the European Union (EU) in accordance with the Medical Devices Directive 93/42/EEC and future Medical Devices Regulation (MDR). This is achieved through close collaboration with the relevant functional groups.

The preparation of relevant documentation needed to support CE marking activities for countries outside of the EU where CE marking is basis for country registration

Skills required:

Good knowledge of CE marking of medical devices. (MDD 93/42/EEC and related directives and guidelines)

Ability to liase with the different functions involved in the elaboration of CE-marking files, Manufacturing, Quality Assurance, R&D, Medical Affairs, Logistics.

Ability to interpret European regulations and guidelines and all technical product information in order to assure that regulatory requirements in the area of medical devices are continuously met.

Excellent interpersonal and collaboration skills and willingness to work in a challenging regulatory environment.

Excellent organizational skills including project management skills.

If you have all of the above and would like to apply for this position, please send your updated CV to