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Project Manager, Regulatory Affairs

Company: Abbott Cardiovascular Sys Inc
Location: Santa Clara
Posted on: November 19, 2021

Job Description:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Project Manager, Regulatory Affairs - Santa Clara, CA or St. Paul, MN

ABOUT ABBOTT

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of STRUCTURAL HEART disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

WHAT YOU'LL DO

We are recruiting for a Regulatory Affairs Project Manager to join our team in the Santa Clara, CA or St. Paul, MN. In this role, you will combine knowledge of scientific, regulatory and business issues to enable products to meet required legislation. You will be responsible for compiling regulatory submissions and ensure data is effectively presented for the registration of products worldwide.

Responsibilities:

  • Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on regulatory requirements for Class III and Class II medical devices
  • Assess the acceptability of documentation for Class III and Class II medical device submissions and effectively communicate regulatory guidance
  • Compile, prepare, review and submit Class III and Class II medical device submissions to regulatory agencies
  • Interact, answer questions and negotiate with regulatory agencies during the submission review process to obtain submission approval
  • Evaluate proposed design and manufacturing changes for regulatory impact and implement any required regulatory action
  • Utilize technical regulatory skills to propose strategies on complex issues
  • Monitor regulatory landscape for impact to company products and help to develop solutions to regulatory obstacles, with other members of regulatory and related teams
  • Ensure compliance with product post marketing approval requirements
  • Review product labeling and promotional material to ensure compliance with relevant regulatory requirements.
  • Help to develop regulatory strategy for Class III and Class II medical devices, with other regulatory team members
  • Provide regulatory support for internal and external audits

    EDUCATION AND EXPERIENCE YOU'LL BRING

    Required:
    • Bachelor's Degree in Engineering, Sciences, or related discipline
    • 8+ years of experience in the medical device industry, including experience with Class II or Class III medical device submissions to regulatory agencies
    • Proficient with MS Office (Word, Excel, Outlook)
    • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

      Preferred:
      • Advanced degree in Engineering, Sciences, or related discipline
      • Previous experience with Class III IDE submissions and/or PMA submissions
      • Experience with Canada, EU and other international medical device regulations and submissions
      • Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization

        WHAT WE OFFER

        At Abbott, you can have a good job that can grow into a great career. We offer:
        • Training and career development, with onboarding programs for new employees and tuition assistance
        • Financial security through competitive compensation, incentives and retirement plans
        • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
        • Paid time off
        • 401(k) retirement savings with a generous company match
        • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

          Learn more about our benefits that add real value to your life to help you live fully:

          Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

          Connect with us at , on Facebook at and on

          JOB FAMILY:
          Regulatory Operations

          DIVISION:
          SH Structural Heart

          LOCATION:
          United States > Santa Clara : Building A - SC

          ADDITIONAL LOCATIONS:
          United States > Minnesota> St. Paul > Woodridge : 177 East County Rd B

          WORK SHIFT:
          Standard

          TRAVEL:
          Yes, 10 % of the Time

          MEDICAL SURVEILLANCE:
          No

          SIGNIFICANT WORK ACTIVITIES:
          Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

          Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

          EEO is the Law link - English:

          EEO is the Law link - Espanol:

Keywords: Abbott Cardiovascular Sys Inc, Santa Clara , Project Manager, Regulatory Affairs, Executive , Santa Clara, California

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