Senior Manager, Regulatory Affairs

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Regulatory Affairs position is a unique career opportunity that could be your next step towards an exciting future.

Summary :

Completes and maintains regulatory approvals and clearances of assigned products.

Key Responsibilities :

• Prepare and oversee documentation packages for submission to Japan 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, PDMA, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files)
• 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. 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 regulatory strategic plans to teams for solutions
• 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 promotional material and labeling content product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy
• Other incidental duties

Education and Experience :

Bachelor's Degree or equivalent in in related field , 5 years years experience of previous related experience Required and

Bachelor's Degree or equivalent in in scientific discipline (e.g., Biology, Microbiology, Chemistry)Experience in preparing domestic and international product submissions Preferred or

Master's Degree or equivalent in (e.g. Pharmaceuticals) Preferred

Additional Skills :