Overview

Reference Number: JO-2002-445497
Senior Regulatory Affairs Specialist
Rate: £40,000 – 45,000
Job Type: Permanent
Location: Hull

Senior Regulatory Affairs Specialist
Medical Devices
Permanent
Officed based Hull
Offering up to 45,000 Per Annum plus additional benefits

Regulatory Professionals is working with an ever-expanding medical device organisation who are seeking a Senior Regulatory Affairs Specialist to be officed based in their East Yorkshire office. Within this position you will be given the opportunity to provide regulatory expertise in the development, maintenance and marketing of pharmaceutical products. The ideal candidate will have prior experience working on Class II products, electrical or class III products within new product development.
Job Requirements include;
Preparing, reviewing and approving data elements for use in regulatory dossiers in accordance with EU and international requirements for medicinal products/clinical trial clearances.
Compiling, reviewing and approving, as required, regulatory despatches in accordance with national requirements to ensure appropriateness and consistency in consistency in content and presentation of information both within and between registration applications.
Deputising for the Regulatory Affairs (RA) Manager, where appropriate and when required
Reviewing and approving artwork, labelling and promotional literature from UK / Group Companies based on acceptability/compliance with regulations/compliance with registered details and in compliance with the Blue Guide as well as advise on its acceptability/compliance with regulations and registered details.
Maintaining marketing authorisations to account for changes in the product or national legislation requirements and licence renewals.
Reviewing and approving change control impact assessments for products

Candidate Requirements include;
Life Sciences degree or equivalent
Prior experience within regulatory across the medical device sector
Good interpersonal, communications and team player skills, high attention to detail, numeracy and the ability to work in a fast paced exciting and deadline driven environment are all essential skills to being successful in this type of role.
The ability to be able to multi-task and juggle projects and tasks simultaneously to keep things on track coupled with strong organisational and prioritisational skills is essential to the success of this role.

If you are interested in discussing this role further, then please email your CV to sophie@regulatoryprofessionals.com or call Sophie on 01189 522 797 to arrange a confidential discussion.

If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*.