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:
• Coursework, seminars, and/or other formal government and/or trade association training required
• 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
• Good ability to read and write English
• Full knowledge and understanding of Japan regulations relevant to medical devices, Class I through Class IV devices
• Full knowledge and understanding of Japan 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 interact professionally with all organizational levels
• 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
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control