Contract Type: Permanent
Location: Yorkshire and the Humber, England
Salary: Negotiable
Start Date: ASAP
Reference: J893629_1510758809
Contact Name: Ben George
Contact Email:
Job Published: November 15, 2017 15:13

Job Description

Principal Regulatory Associate/ QA Officer

Location: Leeds, Bradford, Wakefield, Halifax, Huddersfield, Dewsbury, Harrogate

Type: Permanent

Salary: Competitive plus benefits

Hours: Days

Reports to: Regulatory Affairs Manager

Our Client, a leading Medical Devices company based in Yorkshire are looking to recruit for an experienced Quality/RA specialist who will play a vital part in the growth and development of the QA/RA functions.

The Role:

  • Generation of Technical Files for new products
  • Updating Technical Files as a results of changes to products or regulations (including MDR)
  • Regulatory submissions
  • Assist the Regulatory Affairs Manager as required with
  • Registration in new markets
  • Other day to day issues which are referred to the regulatory team
  • Assist the Technical Quality Manager with technical project work within compliance
  • Assist the Technical Quality Manager with scientific support
  • Undertake any other duties as may be requested by the Regulatory Affairs Manager or Compliance Director

The Person:

  • Will hold a Degree in a relevant Scientific Discipline
  • Will have previous Regulatory or QA experience working directly in a QA/RA based role for Medical Devices (13485) accredited industries
  • Will have the ability to provide scientific/legislative support to team members
  • Will have experience of writing and reviewing technical files
  • Will ideally have Experience of new product registration including both CE and 510(k)
  • Will have Familiarity with medical device sterilization or validation activities
  • Will have Medical device biocompatibility awareness
  • Excellent interpersonal skills, including the ability to work as part of a team and to work with people from across the whole company

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