Regulatory Affairs Specialist
£40-£50ph - Contract
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.
- 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.
- 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
Chester Wrexham Runcorn Warrington Liverpool Manchester Macclesfield
Reg Regulatory Affairs Variances Pharma Pharmaceutical BSC MSc PhD HND
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