C. R. Bard, Inc.

  • Vice President of Regulatory Affairs

    Posted Date 3 months ago(3 months ago)
    Industry / Category
    Medical Device/Regulatory Affairs
    Job ID
    2018-11724
    Career Level
    management
    Division
    Salt Lake City, UT/ Vascular Access Devices - MDS
    Relocation
    Yes
    Location
    US-UT-Salt Lake City
  • Overview

    BARD has now joined BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes. 

     

    Vascular Access Devices, a sub-business unit of Medication Delivery Solutions, focuses on developing, manufacturing, and distributing high-quality medical devices used by clinicians throughout the worldwide healthcare industry to access a patient’s vasculature. Our devices assist in the delivery of chemotherapy, blood products, antibiotics, and nutrition.

    Summary of Position with General Responsibilities

    The Vice President, Regulatory Affairs will be a member of the Vascular Access Devices (VAD) Business Group Leadership team. The VP of RA will be responsible for directing all regulatory affairs activities for VAD to ensure the business unit, corporate and agency global product registration and compliance objectives are met. The VP RA must be able to collaborate with R&D, Marketing and other functional areas to provide his/her regulatory expertise to effectively develop regulatory strategies that successfully lead VAD’s products through the FDA approval process, as well as the numerous other global regulatory agencies. The position reports directly to the WW VP RA MDS Business Unit, with a dotted line to the President/ GM VAD.

    Essential Job Functions

    The following duties and responsibilities are intended to be representative of the work performed by the incumbent(s) in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the position.

    • Ensure worldwide regulatory strategies are clearly delineated, supported and implemented in the development, commercialization and life cycle management of the business’s
    • Member of the VAD Leadership team and VAD Management Committee.
    • Lead the development of global regulatory strategies and timelines for VAD product development projects, working through cross-functional teams to ensure that various pathways are examined early in the process. An assessment of the business risks associated with the preferred regulatory strategies, along with the mitigation plans must be presented to the project team and VAD management in order to keep commercialization progress on
    • Direct and contribute to the preparation and submission of domestic S. [510(k)s, IDEs, and PMAs] and International regulatory filings for the business group products in accordance with policies and procedures established by the company and regulatory agencies
    • Provide appropriate interface for VAD with global regulatory agencies in a variety of pre- and post-market Provide guidance, interpretation and opinions on complex regulatory matters (particularly related to submission pathways), outlining the different outcomes for VA. Maintain active involvement in medical device and regulatory affairs organizations to ensure up-to-date knowledge of current and future industry trends.
    • Develop and maintain outstanding relationships with all regulatory and compliance Serve as liaison between VAD, the FDA, and other international regulatory submission agencies
    • Lead regulatory due diligence assessments and recommendations for acquisitions and/or partnering and product distribution
    • Spearhead the development and implementation of world class policies and procedures in conjunction with MDS and BDX Corporate to enhance operation of the department and ensure overall regulatory
    • Ensure that VAD product labeling and promotional materials are in compliance with FDA, Corporate, and International regulations and
    • Communicate the regulatory affairs strategy to the entire VAD team and each key functional area to inspire proactive attention to this critical area within the
    • Provide technical leadership, training and vision by interpreting regulatory affairs initiatives and mandates, uncovering emerging trends and providing the processes necessary to meet rising Assist in the training of VAD employees with regard to global regulatory requirements and BDX regulatory affairs polices & procedures
    • Provide timely information to the Business unit and Corporate management on issues and accomplishments, performance metrics and significant events
    • Participate as a key member of the Product Development Team.
    • Assess the skills and competencies of the Regulatory, in alignment with the short and long term objectives of the VAD Business Group . Recruit, develop and retain professionals who demonstrate exceptional performance and leadership
    • Ensure bench strength and succession planning through appropriate recruiting, staffing and development of team members.
    • Motivate, mentor and inspire VAD department employees for success including goal setting, performance management, career planning and ongoing evaluation of both individual and departmental
    • Control operational expenses in functional area of responsibility. Actively participate in the preparation of overall expense budget and headcount forecast for Regulatory

    Basic Qualifications

    • Bachelor’s
    • Demonstrated track record of success in leading all areas of regulatory affairs for S. medical devices.
    • Extensive knowledge and experience in designing regulatory and clinical strategies and submissions of product registrations for medical
    • Minimum of ten (10) years of experience in a medical device company with broad experience surrounding regulatory
    • A proven track record of building an effective regulatory affairs

    Preferred qualifications include:

    • Experience in drug/device combination
    • Five years as a Sr. Director or Vice President level in a medical device
    • Past success operating in a large, matrix-managed
    • Bachelor’s or advanced degree in the physical sciences, biomaterials or related
    • Significant experience gaining regulatory approvals for medical devices outside of the United

    Additional Desirable Qualifications Skills and Knowledge

    • Ability to work effectively with corporate officers and staff, medical and technical professionals, FDA and other regulatory
    • Excellent management skills including a proven track record of developing and nurturing high potential
    • Ability to function as an active member of the Leadership Team.
    • Ability to function in a matrix reporting relationship and a team
    • Excellent verbal and written communication
    • Strong understanding of global regulatory environment for medical

    Physical Demands

    This position is in an office and laboratory environment and requires the incumbent to sit, stand and perform general office functions. The incumbent may also be required to lift up to twenty-five pounds occasionally. The incumbent may be required to stand for extended periods of time. Bending, stooping and reaching may also be required.

    Work Environment

    The ideal candidate must be able to work in a team oriented, fast paced environment.  Bard Access Systems is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

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