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Regulatory Affairs Officer

Job Title: Regulatory Affairs Officer
Contract Type: Permanent
Location: Newcastle upon Tyne, Tyne and Wear
Salary: Competitive
Reference: BBBH14389_1643304261
Contact Name: Jacob Golding
Contact Email: jacob@emp-sol.com
Job Published: January 27, 2022 17:24

Job Description

Do you have existing Regulatory Affairs experience?
Or maybe you've worked within QA for many years and have strong knowledge of RA?
Have you also worked within a Life Sciences sector?

We have an opportunity to join a fast-growing Medical Device company as a Regulatory Affairs Officer that are rapidly becoming the go-to provider for PCR COVID testing.

As a Regulatory Affairs Officer you will work closely with the RA Manager as part of a Quality & Regulatory Team.

You will ensure that products and the design and development of future products are compliant to the following regulations: IVDR, REACH, CLP, ISO 13485 & ISO 14971.

You be involved in the compilation and maintenance of medical device files and technical files.

You will also assist in preparing submission dossiers and reviewing product labelling.

Skills and Experience:

Strong Quality or Regulatory experience
Experience working with ISO 13485 & IVDR regulations
Experience with Medical Devices highly desirable
A relevant life sciences degree
Able to work in the UK without restriction

Salary: Competitive (dependent on experience)
Permanent contract
Location: Newcastle upon Tyne

CALL NOW on 0161 839 5353 or email Jacob Golding - jacob@emp-sol.com

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