Regulatory Affairs Specialist

Job Reference: #62160 Add to saved jobs

  • Location Manchester
  • Permanent
  • Sector Medical Devices

Job Summary

Would you like to be responsible for registering a SARS-CoV-2 Test Kit into countries all over the world? This is a unique opportunity for a regulatory affairs specialist to join a dynamic team to help deliver this objective. They are a well-established MedTech company who already have products in the market and have more in the pipeline too!

Job Overview

• The creation, management and maintenance of Technical Files for the company product range in accordance with the requirements of the IVDD 98/79/EC and MDD Directive 93/42/EC, including CE-marking activities.
• Involvement with the IVDR planning transition for the business.
• Experience of country registration processes for worldwide commercial support.
• Prepare regulatory dossiers to support product license applications, import license and product license maintenance for worldwide Regulatory Authorities.
• Proactively manage relationships and communications with regulatory agencies and authorised representatives.
• Support product risk management activities and the life-cycle of marketed products.
• Support for the post market surveillance, preparing reports for the product range, annually.
• Conduct all duties in compliance with GMP, ISO13485, ISO9001, GCP and other regulatory requirements as identified.

Skills Required

• BSc in Science or related field
• Experience (2 years or more) of working in Regulatory Affairs in the IVD or Medical Device Industry
• Global registrations experience desired
• Working knowledge of ISO 13485
• Looking to work in a fast-paced environment

Contact Details

Please contact Nathan Berkley on 0203 019 6020 or email if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.

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