Regulatory Affairs Specialist - Newcastle-under-Lyme, United Kingdom - Brampton Recruitment

Brampton Recruitment
Brampton Recruitment
Verified Company
Newcastle-under-Lyme, United Kingdom

2 weeks ago

Tom O´Connor

Posted by:

Tom O´Connor

beBee Recruiter
Description

  • Relevant Life science or equivalent degree
  • Minimum 2 years exp within medical devices or quality environment
  • Experience in reviewing audit reports

Our client is a global business that are specialists within its field, the company is a successful business that is currently undertaking an expansion, therefore, they are seeking an experienced Regulatory Affairs Specialist to join them.

This role will beresponsible for ensuring regulatory products are registered in accordance with specific country's requirements. Therefore, this role will be responsible for liaising with external bodies regarding regulations.

Job Description for the Regulatory Affairs Specialist is:

  • Creates and maintains global regulatory submissions to support timelines for new/modified product launches/registrations.
  • Leads registrations and submissions for new and existing products.
  • Ensures conformance with applicable regulations in product development, support of claims, content labelling, and promotional materials.
  • Provide Regulatory Affairs support during internal and external audits.
  • Liaise with regulatory authorities and Notified Bodies as required.
  • The report assesses and communicates any changes in regulations.
  • Provides regulatory assessment on complaints.
  • Support Regulatory Affairs Manager in the creation and maintenance of procedures.
  • Act as a mentor to junior regulatory staff members.
  • Support and act as a delegate for activities falling under the remit of the Regulatory Affairs Manager.
It would be good to see Regulatory Affairs Specialists with the following experience:

  • Relevant Life science or equivalent degree
  • Minimum 2 years exp within medical devices or quality environment
  • Experience in reviewing audit reports
  • Experience in reading medical device regulatory requirements
  • Strong time management skills, good prioritisation skills
  • A medical devices qualification would be advantageous

Hours:
Monday - Friday 9:00 am - 5:00 pm

Brampton Recruitment is an independent Commercial and Accounts & Finance recruitment agency working in partnership with employers spanning Stoke on Trent, Staffordshire, Cheshire, and the Greater Manchester region.

More jobs from Brampton Recruitment
See all jobs of Brampton Recruitment