European Regulatory Specialist

European Regulatory Specialist

Department: Regulatory

Location: Victor, NY

Reports to: European Regulatory Manager

Job Summary: The European Regulatory Specialist applies her/his experience, knowledge, organization skills, and communication skills to 1) prepare regulatory submissions, including CE mark applications, for one or more European Notified Bodies as required to market LSI?s new or modified medical devices in Europe, including all relevant maintenance activities; 2) monitor and communicate status of regulatory submissions and perform duties related to regulatory post-market surveillance, and vigilance reporting; 3) provide regulatory feedback and guidance to the company throughout the development cycle; 4) Read and interpret regulations for new and current compliance procedures and regulatory enforcement trends/actions.

Key Tasks & Responsibilities:

  • Participate on product development teams by providing assessment of new devices, proposed changes or enhancements to existing devices, regulatory strategy, timelines, and deliverables ensuring proper European governing requirements are incorporated as part of the development process for products targeted for Europe to ensure timely regulatory submissions and approval.

  • Maintain full Quality and Regulatory compliance with all standards that govern the design, development, manufacture, and distribution of LSI?s medical devices.

  • Provide regulatory feedback and guidance to the company throughout the development cycle.

Education & Experience:

  • Bachelor or Master?s degree, preferably in Life Sciences or Engineering disciplines, with at least 3 years? Regulatory experience (medical devices preferred).

Physical Demands & Work Environment:

  • Sitting, standing, and/or walking for up to eight hours per day.

  • Routine use of standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines.

LSI Solutions is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic.



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