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The primary role of the Senior Regulatory Scientist is to assist in the running of the regulatory affairs by providing input into: regulatory strategies, performing activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets and providing regulatory affairs input for the functional areas.
Clinical & Post-Market Surveillance:
The Post Market Surveillance Specialist 1 assists in the implementation of regulatory strategies, performs activities associated with the EU Authorised representative office. The successful candidate serves as a communication liaison between the Cook manufacturer and the Cook local affiliates or regulatory authorities.