Senior Specialist, Regulatory Affairs Surgical

Edwards Lifesciences•Irvine, CA

6d•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.

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 the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex 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 the preliminary regulatory strategic plans
Prepare and oversee documentation packages for submission to global regulatory agencies
Assist with GUDID submissions
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 labeling content product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy