Regulatory Affairs Specialist

Location: Cheshire, England
Job Type: Contract
Salary: £40 - £50 per hour
Reference: BBBH4174_1577097220
gap technical is committed to the selection, recruitment and development of the best people, basing judgments solely on suitability for the job. By applying for the above position and providing your personal data to us you understand that your data will be processed in line with our Privacy Policy. Whilst we endeavour to respond to all applications individually, due to high volumes, this is not always possible. Thank you for your interest in this role and we look forward to working with you in the future.

Regulatory Affairs Specialist

£40-£50ph - Contract

Cheshire

gap technical are proud to be representing this global manufacturing business in their search for a Regulatory Affairs Specialist to work at their facility based in Cheshire.

Performance Objectives

  • Support the generation and maintenance of market registration documentation communicating with internal staff, and with external partners and regulatory authorities, in respect of registration objectives and submission content.
  • Participates on new product development teams to develop global regulatory strategy and determine what regulatory submissions are required to market the product globally
  • Develops documentation for submissions for new product or new intended uses for existing products in support of domestic and international product marketing approvals.
  • Assists product design and development teams in developing and documenting appropriate design controls.
  • Assure changes are in compliance with global medical device regulations.
  • Review and approve product labelling to assure product and company published literature and labels are compliant with global labelling and marketing regulations
  • Support other functions within the business for information requests, review of artwork and other literature
  • Interprets and utilizes US and international medical device laws and regulations and provide regulatory advice regarding global laws and regulations.

Person Specification

  • Degree in relevant technical or scientific field and or 3-5 years previous Regulatory/QA experience within the pharmaceutical or medical device industries
  • Previous experience within a Regulatory/Quality environment
  • Excellent attention to detail

Locations

Chester Wrexham Runcorn Warrington Liverpool Manchester Macclesfield

KEY WORDS

Reg Regulatory Affairs Variances Pharma Pharmaceutical BSC MSc PhD HND

Apply

Please send your CV and call Aidan at gap technical on 01925 406 525

If you have any questions or are interested in any other opportunities we may have, please do not hesitate to contact on 01925 406 525

This vacancy is being advertised on behalf of gap technical who are operating as an employment agency.

gap technical are committed to the selection, recruitment and development of the best people, basing judgements solely on suitability for the job.

Closing Date: 23/01/2020

"By applying for the above position and providing your personal data to us you understand that your data will be processed in line with our Privacy Policy. To view our full Privacy Policy please go to http://gaptechnical.com/privacy-policies/''