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RA Specialist (Medical Device) Keele

Job Description

Job Description

The Regulatory Affairs Specialist is responsible for ensuring regulatory products are registered in accordance with country specific requirements throughout the organisation.

  • 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.

  • Report, assess and communicate any changes in regulations.

  • Provides regulatory assessment on complaints.

  • Support Regulatory Affairs Manager in creation and maintenance of procedures.

  • Act as mentor to junior regulatory staff members.

  • Support and act as delegate for activities falling under the remit of the Regulatory Affairs Manager.

Candidate Description

  • Bachelor's Degree in a life science or equivalent.

  • Minimum 2-5 Years' experience within Medical Devices Regulatory or Quality

  • Ability to read and understand medical device regulatory requirements and/or standards).

  • Ability to review audit reports and action accordingly.

  • Understanding of, post market surveillance and/or Clinical report writing.

  • Medical Devices training or qualification.

  • Experience within pharmaceutical industry regulatory or quality

  • Knowledge of EU Class III medical device regulation

  • Knowledge of US 510k regulation

  • Knowledge of ISO 13485, ISO14971, ISO10993

  • Previous exposure to global registrations.

  • Previous exposure to notified body/regulatory agency audits.

Application Description

To speak to a recruitment expert please contact Olivia Cann

Employer Description

A fantastic opportunity has come up for a RA Specialist to join an international medical device company that engineers, manufactures, and markets world leading products. Based in Keele, UK, it has global operations across Europe, USA, Canada, China, and India.