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Regulatory Project Manager

Employer
RBW Consulting
Location
Newcastle Upon Tyne, Tyne and Wear (GB)
Salary
£50,000.00 plus benefits
Start date
28 May 2019
Closing date
27 Jun 2019

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Discipline
Regulatory Affairs, CMC, Compliance, Labelling, Regulatory Writing
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

At the forefront of their industry, this innovative endocrinology company working throughout the IVD space are rapidly expanding their facility due to their continued success and are now looking to grow out a dedicated Regulatory Affairs team to help them manage their processes effectively.

As part of this expansion, the company is seeking to bring on board a Regulatory Affairs Project Manager.

This role will report directly into the Head of Regulatory Affairs and will have the responsibility of leading the company’s RA projects for their new and existing products to make sure that they have the quickest time to market possible, whilst remaining in line with the regulatory requirements.

This role will include day to day workloads of preparing and submitting pre-submissions and 510(K) applications and to effectively manage pre and post submission interactions with the FDA and other regulatory bodies.

To be considered for this amazing opportunity, the candidate would need to have:

  • A degree in life science (with a background in R&D if possible)
  • A good background with the design and development of IVDs
  • A good working knowledge of the performance requirements/characterises for IVD products and the ones applicable to CLSI guidelines
  • Working knowledge of IVD regulations (EU IVDD and FDA code of federal regulation) at minimum
  • Good working knowledge of US registration processes (for IVD devices)
  • A background with IVD design and development
  • Minimum of 3 years’ experience in Regulatory affairs in relation to IVD design and registration on market or, the equivalent experience in R&D developing IVDs for international markets (EU and US)

This role is offering a £50,000.00 salary plus benefits and they are looking for someone to start in their beautiful Newcastle offices as soon as possible.

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