- Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues; also keeps management apprised of alternative actions.
- Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans to teams for solutions.
- 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., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files).
- Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process.
- Review product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy.
- A Minimum of 5 years’ experience within medical device regulatory affairs.
- A Bachelor’s degree is required. A science degree is strongly preferred.
- Proven expertise in Microsoft Office Suite Including Word, PowerPoint and Excel.
- Excellent written and verbal communication skills including negotiating and relationship management skills.
- Excellent problem-solving, organizational, analytical and critical thinking skills.
- Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices.
- Full knowledge and understanding of global regulatory requirements for new products or product changes.
- Full knowledge of new product development systems.
- Good leadership skills and ability to influence change.
- Strict attention to detail.
- Ability to manage competing priorities in a fast paced environment.
- Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.