• We use cookies to help make our website work. LEARN MORE

Regulatory Affairs Assistant, Junior

Berkshire   •  £18 - £21 per hour  •  Contract/Temporary, Full time

My client is looking for a Junior Regulatory Affairs Assistant on an 8 month contract paying up to £21.25p/h located in the Wokingham area.

This position is an opportunity to gain broader Medical Devices exposure. Previous experience within Regulatory Affairs and Medical Devices (European) would be preferable.

*Complying with relevant legislation and standards
*Remaining up to date with international legislation, guidelines and customer practices
*Awareness of company's product range
*Understanding of medical devices regulatory documentation
*Developing and writing strategies/arguments/explanations for new product licenses, modifications and license renewals
*Preparing submissions of license variations and renewals
*Planning and communicating timelines for license variations and renewal approvals
*Guiding scientists and manufacturers on regulatory requirements
*Maintaining quality systems and oversight of regulatory inspections
*Revising company practices and providing guidance on systems updates. Liaising with and giving presentations to regulatory authorities
*Submitting license applications to authorities to tight deadlines

Successful graduation in a Life Science degree or equivalent
* Experience of medical device Regulatory Affairs on a European Basis
*Proven capability to interpret legislation and impact to meet commercial needs
*Proven capability of successful working relationships with regulatory bodies
*Show an appreciation and understanding of the positive impact of regulatory in delivering business results

If this may be of interest, please get in touch with Ross Wilson either at rwilson@keypeople.co.uk or on +44(0)1727817621

You must be eligible to work in the UK. Learn more

  • Agency: Key People
  • Contact: Ross Wilson
  • Phone: 01727 817 621
  • Reference: #24069
  • Posted: 5th March 2019
  • Expires: 2nd April 2019

Key People

Share this job: