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Job Details

Regulatory Specialist

Company: RBW Consulting
Location: Hertfordshire
Reference: LCB/RAS/MED/0001
Closing Date: 02 Sep 18
Type: Full Time
Salary (£): 40,000 - 60,000
Benefits: Standard

Job Summary:

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.

Requirements:

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!

Apply for this job: Regulatory Specialist

Contact Information:

Address:  Brighton
Southdown House, 130a Western Road, Brighton BN1 2LA
BN1 2LA
England
Tel:  01293 584 300

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