Responsibilities New Product Development Act as Regulatory Affairs lead for the new product development projects, provide "solution-based" advice to development teams Develop and maintain regulatory strategies for new and modified product/product families Prepare and implement regulatory filings, including technical files, Canadian submissions, and letters to file.
Conduct international registrations in accordance with and in support of regulatory strategies Provide input on and approve product labels and labelling, including language requirements worldwide Support set up and management of outside vendors such as License holders and In Country agents [including importers, distributors], as needed.
Change Management Provide regulatory guidance on changes to existing products Supervise global regulatory intelligence and provide impact evaluation of changing regulations.
Performing regulatory impact assessments for engineering changes Review and approve promotional materials Post Market Provide regulatory input to support post-market surveillance and vigilance activities Support Health Hazard Assessments and Field Actions as needed Leadership Support generating a strong Quality culture within the Clinical Business Unit through effective collaboration with peers.
Act as Subject Matter Expert within 3rd party and internal audits Manage and maintain Regulatory Affairs internal policies and procedures Provide guidance to regulatory specialists as needed to support regulatory and/or clinical strategy requirements.
Qualifications Education: A bachelor's degree or equivalent experience is required, preferably in Analytical Chemistry, Biochemistry, or Biomedical Engineering.
Graduate education or equivalent experience is preferred.
Experience: Regulatory affairs experience in the In Vitro Diagnostic Medical Device environment, or equivalent Knowledge and application of 21 CFR 820 and ISO ***** is required Knowledge and application of the European IVD regulations is required, IVDR preferred First-hand experience with preparation and execution of regulatory filings such as pre-Submissions, premarket notifications,