Regulatory Affairs Specialist (Medical Devices)

REF: 903798_1592411773

  • Position: Permanent
  • Salary: Not Disclosed
  • Location: Rest of Ulster

MCS Group is working in partnership with our client, a manufacturing devices organisation in Co. Antrim to recruit a Senior RA/QA Specialist for their team.

This is a brand new role for the business and has come around through new projects and successful growth. This company have a wide range of markets and as a result they require an additional specialist to join their Quality team.

This is a unique combination role of both Regulatory Affairs and Quality Assurance duties and will suit an experienced individual within the area of Medical Devices.

Your overall purpose within the role will be to support the company's products for license renewals, periodic updates and registrations to regulatory agencies and become an integral member of the QA team.

The successful candidate:-

  • You will hold a Degree in Engineering or other relevant science subject or have extensive work experience within this area.
  • You will have experience in a design and/or manufacturing RA/QA role in a medical device, IVD Device or OTC environment, with current working knowledge of European regulations for medical and IVD devices including ISO 14971, and ISO 13485:2016.
  • You will be able to demonstrate that you have experience compiling and maintaining CE technical files and interacting with notified bodies

To speak in absolute confidence about this opportunity please send an up to date CV via the link provided or contact Kirsty Dillon Specialist Consultant at MCS Group 028 9023 5456

Even if this position is not right for you, we may have others that are. Please visit MCS Group to view a wide selection of our current jobs

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