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!
• 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.
• 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
Please contact Nathan Berkley on 0203 019 6020 or email firstname.lastname@example.org if you would like to know more about this opportunity or similar within Medical Devices. This will be 100% confidential.
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Find out more about us at www.peoplewithchemistry.com and https://www.linkedin.com/in/nathan-berkley-a25811139/