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Edwards Lifesciences: Senior Specialist, Regulatory Affairs Sustaining - Transcatheter Heart Valve

Company: Edwards Lifesciences
Location: Irvine
Posted on: October 15, 2020

Job Description:

The Regulatory Affairs Senior Specialist role is an outstanding opportunity to be a part of the Edwards Lifesciences Transcatheter Heart Valve 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 RA Specialist is responsible for completing and maintaining regulatory approvals and clearances of assigned products.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 plansPrepare 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 processReview labeling content product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracyOther incidental dutiesEducation and Experience:A Bachelor’s degree in a related field is required; a scientific disciplineis preferred.A minimum of three years of related experience is required with a Bachelor’s degree, OR, a minimum of one year of related experience is required with a Master’s degree.Coursework, seminars, and/or other formal government and/or trade association training is requiredExperience in preparing domestic and international product submissions is preferredAdditional Skills:Proven expertise in Microsoft Office Suite including Word, PowerPoint and ExcelExcellent written and verbal communication skills including negotiating and relationship management skillsExcellent problem-solving, organizational, analytical and critical thinking skillsFull knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devicesFull knowledge and understanding of global regulatory requirements for new products or product changes.Full knowledge of new product development systemsGood leadership skills and ability to influence changeStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast paced environmentMust be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projectsAbility to interact with senior internal and external personnel on significant matters often requiring coordination between organizationsAdhere to all EHS rules and requirements 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/controlEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Keywords: Edwards Lifesciences, Irvine , Edwards Lifesciences: Senior Specialist, Regulatory Affairs Sustaining - Transcatheter Heart Valve, Other , Irvine, California

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