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Regulatory Affairs professional (12 month FTC)

We are a global life sciences company and innovator in the design, development and manufacture of medical devices.

Due to increased workflow we have an exciting opportunity for a Regulatory Affairs professional to join our highly motivation team on a 12-month fixed term contract basis.

As a Regulatory Affairs Specialist reporting to our RA Manager you'll be responsible for preparing, obtaining and submitting country specific registration documentation to support the company name change.

Playing a major role in RA you'll deploy your talents in coordinating additional project changes and combining registration activities where applicable as well as support the updating of Technical Files.

You will be creating and maintaining registration database and provide weekly accomplishments to the RA manager and project team.

Your key responsibilities will also include:
, Reviewing and/or researching country-specific requirements for registration purposes
, Helping to establish and maintain an information network for purposes of monitoring registration activities and the coordination of implementation of the company labelling into manufacturing.
, Preparing regulatory documentation / dossiers for submission to Health Authorities of regulatory files such as STED and Technical Documentation (if applicable)

Ideally educated to Bsc or Msc level in a related field you'll have a proven track record in regulatory affairs, preferably working at a medical device or pharma company for at least 3 years, but certainly with a demonstrable ability of good communicational and coordination skills with high attention to details.

Happy working autonomously and generating, prioritising and handling your own work, you've got the skills to work in a team as well.

You'll also bring:
, A sound knowledge of Medical Device CE Marking Directive 93/42/EEC (and its amendments)
, Experience in worldwide registrations
, Excellency in Excel and Word

Person Specification & Essential Skills
, A BA/BS degree is required.

Preferred education/experience areas include health care, physical, biological, and regulatory sciences, clinical, engineering, potentially coupled with advanced degrees (MS, MBA, PhD, etc.)
, Sound knowledge of Medical Device CE Marking Directive 93/42/EEC (and its amendments)

Orion Electrotech Ltd acts as both an Employment Business and Employment Agency and complies with the Conduct of Employment Agencies and Employment Businesses Regulations Act 2003.

  • Start: ASAP
  • Duration: 12 month FTC
  • Rate: Up to £35000 per annum + £neg. DOE + Benefits
  • Location: Reading, England
  • Type: Permanent
  • Industry: Engineering
  • Recruiter: Orion Electrotech Ltd
  • Tel: 0118 9239 239
  • Fax: 0118 9753 332
  • Email: to view click here
  • Posted: 2017-11-28 16:20:13 -

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