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Regulatory Operations Specialist I

Company: St. Jude Medical, Cardiology Division, I
Location: Santa Clara
Posted on: November 22, 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:

Regulatory Operations Specialist I - St. Paul, MN or Santa Clara, CA

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 Operations Specialist I to join our team in the St. Paul, MN or the Santa Clara, CA location. In this role, you will be responsible for specialized level work assignments and/or analyses, evaluation, preparation, and management of global regulatory product releases and general support of global regulatory activities.

Responsibilities:

  • Daily support of product releases by assisting Regulatory Specialists on Product Release Authorization (PRA) submission and approvals allowing shipment of product to achieve departmental and organizational objectives.
  • Responsible for following SOPs for managing regulatory documents in Global Product Registration (GPR) system and Product Release Authorizations (PRAs) and overall regulatory operations activities.
  • Acts as a regulatory representative responsible for review and analysis of GTS blocked orders, providing guidance and direction on regulatory compliance.
  • Participate and lead regulatory departmental process improvement initiatives
  • Monthly collection and analysis of data for key performance indicators (KPIs) of Regulatory department. Assist drafting departmental monthly reports and presentations.
  • Ensure communications convey all necessary detail and adhere to applicable regulatory standards.
  • Represent Regulatory Operations in cross-functional interactions with Supply Chain, Customer Support, Quality, Marketing, In-Country affiliates and IT.
  • Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.
  • Participates in projects affecting GPRs and PRAs and performs other related duties and responsibilities, as assigned

    EDUCATION AND EXPERIENCE YOU'LL BRING

    Required:
    • Bachelor's degree
    • 1+ years of experience working in a regulated manufacturing environment (i.e. medical device, pharmaceutical, aerospace, etc), including working with and manipulating data
    • Proficient with MS Office suite (Word, Excel, Outlook)
    • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

      Preferred:
      • Advanced level degree
      • Medical device experience
      • Experience working with Windchill

        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 > Minnesota > St. Paul > Lillehei : One Lillehei Plaza

          ADDITIONAL LOCATIONS:
          United States > Minnesota > St. Paul > Tech Center : One St Jude Medical Drive

          WORK SHIFT:
          Standard

          TRAVEL:
          Yes, 5 % of the Time

          MEDICAL SURVEILLANCE:
          Not Applicable

          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: St. Jude Medical, Cardiology Division, I, Santa Clara , Regulatory Operations Specialist I, Other , Santa Clara, California

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