Regulatory Affairs Specialist

Manchester Permanent
  • Excellent opportunity to work for an international molecular diagnostics company
  • Excellent opportunity to join a dynamic team, working on exciting IVDR projects

About Our Client

My client is a leading molecular diagnostics company that develops, manufactures, and commercialises molecular diagnostic solutions.

Job Description

  • The maintenance of Technical Documentation Files for company device range in accordance with the requirements of the IVDD 98/79/EC and IVDR (EU) 2017/746 for CE-marking activities.
  • Administrate regulatory dossiers to support product license applications, import license and product license maintenance for worldwide Regulatory Authorities.
  • Maintain specialist knowledge and tracking of the regulatory requirements within each of operational geographical territories.
  • Support for the development of the companies regulatory planning, incorporating strategies for the product range in accordance with global requirements.
  • Support product risk management activities and the life-cycle of marketed products.

The Successful Applicant

1-2 years experience in working within Medical Devices (Regulatory Affairs role)

IVD experience would be advantageous

Degree in a life science or equivalent either in genetics or molecular biology and significant experience working within a regulatory affairs arena.

What's on Offer

Competitive package available

Kelly Percival
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Phone number
+44 1727 730 143

Job summary

Life Sciences
Regulatory Affairs
Healthcare / Pharmaceutical
Contract type
Consultant name
Kelly Percival
Consultant phone
+44 1727 730 143
Job reference