Regulatory Affairs Specialist

DEP ON EXP
Newcastle under Lyme

KD/L6394VXW
Permanent

Karen Dennis
01270 629090 ext 301

As Regulatory Affairs Specialist you will be responsible for ensuring all regulatory products are registered in accordance with country specific requirements.

 

Key duties and responsibilities will include:

  • Creating and maintaining global registry submissions to support new/modified product launches and registrations
  • Ensuring conformance with appropriate regulations in product development, content labelling and promotional materials
  • Providing support during internal and external audits
  • Liaising with regulatory authorities and notified Bodies as required
  • Reporting, assessing and communicating any changes in regulations
  • Providing regulatory assessment on complaints
  • Supporting the Regulatory Affairs Manager in creating and maintaining procedures
  • Acting as a mentor to more junior team members

 

Key skills and experience required:

  • Experience working within a regulatory or Quality role within medical devices is essential
  • Ability to read and understand medical device regulatory requirements/standards
  • Ability to review and action audit reports
  • Ability to understand post market surveillance and clinical report writing
  • Ability to prioritise large amounts of changing, complex information

 

Candidates mush have a Degree (or equivalent) in a life science, and must be able to work with minimal supervision.

 

Hours of work: Monday – Friday, 9.00am – 5.00pm

Holidays: 25 days + bank holidays

Onsite parking

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