International Regulatory Affairs Specialist

Bridgewater, NJ

Industry: Regulatory & Scientific Job Number: 134480

International Regulatory Affairs Specialist

 

Background: The client is a Medical Device/Pharmaceutical company that is taking on a large International Regulatory Affairs project. They are looking for a consultant with a strong background in International RA, specifically on the medical device side to help with global product registrations as well as EU MDR remediation. The consultant will be responsible for the execution of global registrations in markets such as APAC, EU, Latin America, EMEA, and Canada. They will also act as a link between the US Regulatory Affairs team and the global teams ensuring communication and efficiency. The client needs someone who has expertise on the medical device RA side, but also needs baseline knowledge of validation/verification to communicate with the Quality and R&D teams. The client will also use this consultant for support with Technical File remediation on their EU MDR team, so experience with EU regulations is also a must. They have a strong preference for a consultant with a science background and at least a Bachelor’ s degree in a scientific field.

Project: The consultant is expected to come onto the team and act as a link between the US and Global teams. They will provide communication between those teams as will as interact with their Quality and R&D teams to ensure the right information/documentation is included in their global registrations. Because of this, the consultant needs to have excellent communication and organizational skills. They are registering their products in over 90 countries, and this consultant is expected to do hands-on execution of the registrations for markets such as APAC, EU, Latin America, EMEA, and Canada. They will also be involved in a hands-on support role for the client’ s EU MDR Technical File remediation efforts. Because the role involves significant hands-on execution work, the consultant is expected to have a strong depth of experience with global registrations and Technical File remediation.

Required:

Medical Device Regulatory Affairs

International Registration Experience

Technical File Updates to EU MDR Standards

Communication and Organizational Skills

 

Job Type: Contract 

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