Pay Range $48-$50 per hr. Depending on experience level
Purpose: Completes and maintains regulatory approvals and clearances of medical device products.
Key Responsibilities:
1. 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.
2. Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.
3. 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.
4. 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)
5. Provide guidance on regulatory requirements necessary for contingency planning
6. 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
7. 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
Additional Skills:
-Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
-Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations Develop solutions to a variety of complex problems.
-Contributes to process improvements
-Exercise judgment within defined procedures and practices to determine appropriate regulatory action/requirements for new products or product changes and preparation of regulatory documents.
Education and Experience:
-Bachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)
-5-7 years of experience required
