Regulatory Specialist

Recruiter
RBW Consulting
Location
Bedfordshire
Posted
10 Oct 2018
Closes
14 Oct 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Hertfordshire, UK

£40,000.00 - £50,000.00

Medical Devices



Company Overview

A global Medical Device company that owns several leading Medical Device brands currently based in Hertfordshire with multiple global locations etc.

The award-winning enterprise (headquartered in the USA) is going from strength to strength and is looking to employ more staff within Regulatory and Quality over the next few years with the view to training people up and developing them through their in-house career tree.

This company are one of the largest hospital suppliers for Medical Devices and considered a household name.



Role Responsibilities


Act as responsible party for all regulatory aspects of the CE marking process for the relevant Medical Devices with a large emphasis on the ongoing lifecycle maintenance and compliance
Registering and maintaining technical files in the EU in accordance with all Medical Device Directives
Act as point of contact for internal stakeholder questions etc.
Lead the preparation, planning and execution of regulatory submissions as well as the ongoing maintenance etc.




Individual Requirements


Good exposure to CE Marking of Medical Devices
Degree in Life Sciences
3-5 years of experience in RA and QA
Ability to understand EU regulations and guidelines and all technical product information
Understanding of new MDR




If this sounds like the kind of role that you could be interested then – APPLY NOW!

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