Senior Regulatory Affairs Specialist (Medical Devices)

Location
Hertfordshire
Salary
40,000 - 60,000
Posted
02 Jan 2019
Closes
01 Feb 2019
Ref
JL 02/01
Discipline
Quality, QA / QC
Contract Type
Permanent

I am currently working with a very well established Medical Device company who are looking for a Permanent Senior RA Specialist to join the team based in Hertfordshire.

The key responsibilities of the RA Specialist will include:

  • Establish, manage and maintain good relationships with the local regulatory authorities in the region
  • Interacts directly with regulatory authorities personnel and coordinate post-market surveillance activities, for all business units.
  • In direct interaction with the business divisions, support the preparation, conduct and follow-up of regulatory authorities meetings on post-market surveillance matters.
  • Coordinate the preparation, review and submit timely responses to requests for additional information from regulatory authorities on vigilance and other post-market surveillance matters in the region.
  • Plan, execute and maintain product registrations with regulatory authorities for his/her respective product lines, in accordance with product launch plans, as applicable in the region.
  • Review and approve promotional and advertising materials in compliance with BSC Corporate policy and applicable national regulations.
  • Establish and maintain a good working relationship with regional regulatory affairs, cross-functional peers and business units to gain positive & timely support.
  • Serve as regulatory consultant to marketing and government teams as required.

The salary for the Senior RA Specialist will depend on your experience but could range anywhere from £40,000 to £50,000 per annum + an excellent and extensive benefits package.

If you would be interested to know more and think you have a suitable background in Regulatory Affairs within the Medical Devices industry, then apply online with your most up to date CV and give Jack Lundgren a call on 0207 812 7700.

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