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Sr Specialist, Regulatory Affairs, Critical Care

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: November 19, 2021

Job Description:

We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Sr Specialist, Regulatory Affairs - Critical Care USA - California - Irvine The Sr Specialist, Regulatory Affairs will support the Critical Care business unit with 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 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
--- Other incidental duties

Education and Experience:
Bachelor's Degree in related discipline plus minimum 5 years experience required
(or Master's Degree in related discipline plus minimum 3 years experience)
Experience in preparing domestic and international product submissions strongly preferred

Additional Skills: --- Experience and understanding of global regulations relevant to medical devices, Class II and/or Class III devices --- Experience and understanding of global regulatory requirements for new products or product changes. Experience or knowledge of new product development systems --- Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel --- Excellent written and verbal communication skills including negotiating and relationship management skills, ability to influence change --- Excellent problem-solving, organizational, analytical and critical thinking skills --- 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 --- Adhere 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/control E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Posted 3 Days Ago Full time Req-9175 About Us Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.-- For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

Keywords: Edwards Lifesciences Gruppe, Irvine , Sr Specialist, Regulatory Affairs, Critical Care, Other , Irvine, California

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