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    Senior Specialist, Regulatory Affairs - Irvine, United States - Orange County Regulatory Affairs Discussion Group (OCRA)

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

    1 week ago

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    Description
    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).

    #J-18808-Ljbffr
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