Senior Specialist, Regulatory Affairs

2 weeks ago

Irvine, United States Orange County Regulatory Affairs Discussion Group (OCRA) Full time

Senior Specialist, Regulatory Affairs, Sustaining Products, THV The Regulatory Affairs Senior Specialist role is an outstanding opportunity to be a part of the Edwards Lifesciences Transcatheter Heart Valve (THV) program, one of the medical device industry’s most groundbreaking technological innovations. Edwards has a strong pipeline in this space and the regulatory pathway is critical to getting these lifesaving products to our clinicians and patients. The Senior Specialist is responsible for completing and maintaining regulatory approvals and clearances of THV sustaining products. Please note this is a high-engagement, office-based position on Edwards’ beautiful campus in Irvine, California. We provide relocation assistance. Key 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 technical documentation and GSPR) 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 Other incidental duties Bachelor's Degree in a related field and 5 years of previous related experience Or Master’s Degree in a related field and 3 years of previous related experience Coursework, seminars, and/or other formal government and/or trade association training Medical device experience Preferred Qualifications: Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices, with focus on US and EU regulatory requirements Full knowledge and understanding of global regulatory requirements for product changes. Experience in preparing domestic and international product submissions Excellent written and verbal communication skills including negotiating and relationship management skills Additional Skills and General Expectations: Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel Excellent problem-solving, organizational, analytical and critical thinking skills 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 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 $86,000 to $121,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

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