Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements. Present alternatives for meeting regulatory requirements and resolve moderately complex conflicts between those requirements and development issues, also keeps management apprised of alternative actions.
Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.
Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans. Prepare and oversee documentation packages for submission to global regulatory agencies. Track timelines and documents milestone achievements for inclusion in regulatory submissions.
May interact with regulatory agencies as part of submission review and on-site audit support (e.g., US FDA, EU notified bodies, Japan PMDA, Australia TGA, Japan PMDA, other global regulatory agencies, submissions, dossiers and technical files)
Provide guidance on regulatory requirements necessary for contingency planning
Monitor proposed and current global regulations and guidance; assesses impact of such regulations and guidance on assigned project(s); proposes suggestions on utilizing regulatory updates to expedite approval process
Review labeling content, product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy
Experience:
Experience with EU MDR strongly preferred
Coursework, seminars, and/or other formal government and/or trade association training required
Proven expertise in Microsoft Office, Adobe.
Experience in product lifecycle management systems (Agile, Teamcenter etc.) preferred
Excellent written and verbal communication skills and interpersonal relationship skills
Excellent problem-solving, organizational, analytical and critical thinking skills
Education and Experience:
Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)