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The Regulatory Affairs Specialist 2 helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The Regulatory Affairs Specialist 2 serves as a communication liaison between the Cook manufacturer and the Cook local affiliates, distribution partners or regulatory authorities.
Reporting to: Team Lead, Regulatory Affairs or
Manager, Regulatory Affairs
Find out more about Cook Medical here
Clinical & Post Market Surveillance:
The Regulatory Scientist 2 will be involved in the development and generation of post market surveillance (PMS) plans and reports for Cook Ireland medical devices. In addition, the Regulatory Affairs Specialist will perform activities associated with PMS, including Post Market Clinical Follow-Up (PMCF), and Clinical Evaluation Plans and Reports (CEPs, CERs).
Reporting to: ...
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.