Job Details

• As a contributor to the regulatory affairs team, you will support compliance to the upcoming EU Medical Device Regulations.
• Specifically, you will be assigned various regulatory activities including but not limited to: review and update to Technical Files and/or Design Dossiers, gap assessment for current files under EU Medical Device Directive to EU Medical Device Regulations, and/or input into product labeling or procedure revisions to demonstrate compliance.
• The individual will be working with various work stream leads to identify gaps, develop strategy on closing the gaps, and help execute against the strategy, AND/OR you will support the execution of the project plan to ensure facilitate international registration requests by acting as a liaison between the Division teams and the International RA Affiliates Specifically, you will be responsible for evaluating, preparing and submitting international registrations with a focus on timeliness and follow-through to ensure a positive outcome.
• You will be working with cross-functional team members to evaluate documentation within regulatory repository as well as design history files to enable compilation of international submissions

• Minimum of 4-5 years’ experience with medical devices sold in the EU/US
• Strong working knowledge of EU regulations including experience with developing and preparing submissions for EU Notified Bodies (Technical Files and Design Dossiers)
• Knowledge/Working experience on US FDA/China NPMA is preferred
• Experience with orthopedic devices is preferred
• Prior experience collaborating in cross-functional development teams providing feedback as the RA representative
• Prior experience working on new EU Medical Device Regulation implementation projects and/or large enterprise projects desired
• Knowledge on ISO 14971/ISO 10993 standards

Reference ID - GH/PHL/JC//25102019//87359/Senior Regulatory Affairs