Edwards Lifesciences LLC
Edwards Lifesciences LLC United States United States
2 months ago
Manager, Regulatory Affairs- Surgical Structural Heart
This position, Manager, Regulatory Affairs in Surgical Structural Heart, is an exciting opportunity to participate in the total product lifecycle of surgical bioprosthetic valves as a Regulatory Subject Matter Expert in a fast-paced, collaborative environment...
• Represent the regulatory function on manufacturing and product development teams as a subject matter expert (SME) to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues; also recommends multiple solutions for selection by management.
• Prepare formal Regulatory Plans (global regulatory strategy documentation).
• Review promotional material, labeling content, protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.
• Prepare, provide direction, and oversee documentation packages for submission to global regulatory agencies. 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).
• Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing regulatory strategic plans and leading teams to implement solutions.
• Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on multiple projects, propose suggestions and lead the implementation on utilizing regulatory updates to expedite approval process.
• Other incidental duties as assigned by Leadership
Education and Experience:
• Bachelor's Degree in related field of study or in scientific discipline (e.g., Biology, Microbiology, Chemistry) Plus 8 years previous related experience OR Master's Degree in related field of study or in scientific discipline Plus 6 years previous related experience required.
• Experience in preparing domestic and international product submissions required
• Experience with EU MDR preferred
• Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Extensive knowledge and understanding of global regulations /requirements relevant to medical devices (US Class III preferred)
• Extensive knowledge of new product development systems
• Strong leadership skills and ability to influence change
• Keen attention to detail
• Ability to interact professionally with all organizational levels and across global manufacturing sites
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including serving as consultant to management
• Ability to interact with regulatory agencies and international regulatory partners
• 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
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California, the base pay range for this position is $111,000 to $158,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience
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