Regulatory Affairs Specialist - Oklahoma City, United States - J&J Family of Companies

    J&J Family of Companies
    J&J Family of Companies Oklahoma City, United States

    Found in: beBee S2 US - 1 month ago

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    Description

    Regulatory Affairs Specialist W

    Description

    Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Regulatory Affairs Specialist. Remote work options may be considered on a case-by-case basis and if approved by the Company

    Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

    The Regulatory Affairs Specialist will be responsible for preparing regulatory documents and submissions according to Abiomed standards. You will work closely with Regulatory Affairs team members and cross-functional staff members to support Regulatory programs. Through your engagement in this role, you will help shape the life-saving field of heart recovery.

    The ideal candidate will:

    • Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices
    • Be energized by joining a world-class company and regulatory team
    • Enjoy teamwork and thrive as a member of dynamic cross-functional teams
    • Build and maintain strong interpersonal relationships within and outside of the company
    • Exhibit leadership traits- positive, forward looking, accountable, action-oriented, delivering results
    • Adaptable and thrive in a dynamic work environment where variety is the routine.
    • Embrace change, continuous learning, and work skills improvement

    Key Responsibilities:

    • Prepare FDA submissions and other regulatory documents including 510(k)s, IDEs, Qsubs, PMA Supplements, PMA Amendments, and PMA Annual Reports
    • Create, review and approve engineering changes and make reportability decisions per FDA guidance documents
    • Actively participate on project teams, review and approve protocols and reports to support regulatory submissions
    • Review relevant guidance documents and provide interpretative assistance for new filings
    • Communicate regulatory plans and project status to internal stakeholders

    Qualifications

    Education

    • Bachelor's Degree in engineering or science required
    • Advanced degree is preferred

    Required

    • Minimum of 2 years of regulatory affairs experience in the medical device industry with a track record of successful submissions.
    • Must have excellent communication and organizational skills
    • Must have effective regulatory writing skills
    • Must be able to execute tasks in a timely manner with minimal supervision
    • Must be able to prioritize tasks
    • Must be proficient in Microsoft Office Suite, including MS Teams

    Preferred

    • Class III Cardiovascular medical device experience
    • Have demonstrated ability to make regulatory determinations for manufacturing changes

    Other

    • Travel up to 10%
    • Must be able to effectively work remotely

    This job posting is anticipated to close on The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications.

    For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $88,000 to $123,000. The Company maintains highly competitive, performance-based compensation programs. . Additional information can be found through the link below. For additional general information on company benefits, please go to:

    Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

    Primary Location NA-US-4887-Danvers

    Other Locations NA-United States

    Organization ABIOMED Inc.(6942)

    Job Function Regulatory Affairs

    Req ID: W