Senior Specialist, Regulatory Affairs Surgical

Edwards Lifesciences•Irvine, CA

9d•$92,000 - $130,000•Onsite

About The Position

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives. Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you'll make an impact: Represent Regulatory Affairs on heart valve repair product development and manufacturing teams, providing regulatory input across the full product lifecycle, including design, verification/validation, clinical evaluation, and post-market activities. Present regulatory options for meeting requirements and resolve moderately complex conflicts between regulatory expectations and development or manufacturing constraints; keep management informed of risks and alternative approaches Review and approve protocols, reports, engineering drawings, procedures, labeling, and other design and manufacturing documentation to ensure compliance with applicable regulatory requirements, consistency, and technical accuracy for cardiovascular implantable devices Provide regulatory guidance to support strategic and contingency planning, including development of preliminary and project-level regulatory strategies for heart valve repair technologies across U.S. and international markets Prepare, compile, and support global regulatory submissions for assigned products, including: U.S. submissions (e.g., 510(k)s, IDEs, PMAs, PMA supplements, annual reports) EU submissions under the Medical Device Regulation (MDR) (e.g., Technical Documentation, Design Dossiers, STEDs, clinical evaluation documentation, and responses to Notified Body questions) Support CE marking activities and interactions with Notified Bodies for Class III implantable devices Assist with GUDID/UDI submissions and maintenance of device registration and listing information Track regulatory timelines, submission content, and documentation milestones to support on-time approvals and lifecycle compliance. Participate in interactions with regulatory authorities and Notified Bodies, including submission review questions, deficiency responses, audits, and inspections, under the guidance of senior regulatory leadership Monitor and assess global regulatory regulations, standards, and guidance relevant to heart valve repair and cardiovascular implantable devices; evaluate impact to assigned projects and propose approaches to mitigate risk or support efficient approvals Review and approve labeling, product and process changes, and post-approval documentation to ensure ongoing regulatory compliance throughout the product lifecycle Support post-market regulatory activities, including change assessments, vigilance inputs, and regulatory impact analyses for design or manufacturing updates

Requirements

Bachelor's Degree & a minimum of 5 years related experience OR equivalent based on Edwards criteria
Coursework, seminars, and/or other formal government and/or trade association training

Nice To Haves

Bachelor’s degree in scientific discipline (e.g., Biology, Microbiology, Chemistry)
Experience in preparing domestic and international product submissions
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
Strict attention to detail

Responsibilities

Represent Regulatory Affairs on heart valve repair product development and manufacturing teams, providing regulatory input across the full product lifecycle, including design, verification/validation, clinical evaluation, and post-market activities.
Present regulatory options for meeting requirements and resolve moderately complex conflicts between regulatory expectations and development or manufacturing constraints; keep management informed of risks and alternative approaches
Review and approve protocols, reports, engineering drawings, procedures, labeling, and other design and manufacturing documentation to ensure compliance with applicable regulatory requirements, consistency, and technical accuracy for cardiovascular implantable devices
Provide regulatory guidance to support strategic and contingency planning, including development of preliminary and project-level regulatory strategies for heart valve repair technologies across U.S. and international markets
Prepare, compile, and support global regulatory submissions for assigned products, including: U.S. submissions (e.g., 510(k)s, IDEs, PMAs, PMA supplements, annual reports) EU submissions under the Medical Device Regulation (MDR) (e.g., Technical Documentation, Design Dossiers, STEDs, clinical evaluation documentation, and responses to Notified Body questions)
Support CE marking activities and interactions with Notified Bodies for Class III implantable devices
Assist with GUDID/UDI submissions and maintenance of device registration and listing information
Track regulatory timelines, submission content, and documentation milestones to support on-time approvals and lifecycle compliance.
Participate in interactions with regulatory authorities and Notified Bodies, including submission review questions, deficiency responses, audits, and inspections, under the guidance of senior regulatory leadership
Monitor and assess global regulatory regulations, standards, and guidance relevant to heart valve repair and cardiovascular implantable devices; evaluate impact to assigned projects and propose approaches to mitigate risk or support efficient approvals
Review and approve labeling, product and process changes, and post-approval documentation to ensure ongoing regulatory compliance throughout the product lifecycle
Support post-market regulatory activities, including change assessments, vigilance inputs, and regulatory impact analyses for design or manufacturing updates