Regulatory Affairs Specialist - Leeds

  • Salary: Competitive
  • REF Number: 00034966
  • Consultant: Robert Walker
  • Contact: 01246 47 55 00
  • Date Published: 28.01.2016
  • Closed Date: 12.05.2016
  • Sector: Medical Devices
  • Location: Yorkshire
  • Discipline: Regulatory Affairs

Rob Walker at CK Science is recruiting for a Regulatory Affairs Specialist to join a leading medical device company based in Leeds. This position is a contract role for the duration of 6 months.

As a Regulatory Affairs Specialist, the main purpose of your role will be to compile Summary Technical Documentation ( STeD) in accordance with the requirements of the Medical Devices Directive 93/42/EEC and internal templates / procedures.

Further responsibilities of this Regulatory Affairs Specialist position will include:

  • Gathering information and data from multiple business partners and internal data systems.
  • Compiling accurate summary technical documentation files for a range of orthopaedic medical devices ( Class I to III) to project plans.
  • Following and promoting Company, HS&E and Quality procedures and standards to enable the site to achieve and maintain excellent results.
  • Carrying out such further tasks that may be delegated by the immediate manager.

As a Regulatory Affairs Specialist, you will have the following qualifications, skills and experience:

  • A good first degree in a relevant scientific discipline and/or significant area of expertise developed through experience and positive track record.
  • Significant regulatory experience regarding the compilation of technical files and design dossiers. Working knowledge of the STeD format would be desirable.
  • Ability to demonstrate projects undertaken have been satisfactorily completed within agreed timescales.
  • Possess computer competency in Microsoft office software, data collection and general analysis tools.
  • Ability to review and assess technical documentation and determine compliance with the Medical Devices Directive.
  • Strong organization skills, with proven track record in managing large amounts of data whilst maintaining accuracy.
  • Ability to work independently.

For more information or to apply for this Regulatory Affairs Specialist position please contact Rob Walker on 01246 457700 or email Alternatively please click on the link to apply online now.

CK Science is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference SH34966 in all correspondence.

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