1+ months
2018-05-022018-10-10

Postmarket Surveillance Clinical Group Lead

Abbott
Los Angeles, CA

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.


Job Summary:

The Clinical Group Leader serves as the expert resource when medical input is required.

Key responsibilities include, but are not limited to, the following:

  • Serve as the clinical and technical interface between the medical community and various departments, most frequently Postmarket Surveillance
  • Provide clinical expertise and opinions for cardiac pacing products, for all levels of the organization
  • Apply medical and product knowledge to determine reportability of product complaints (malfunctions and adverse events) to global regulatory bodies (e.g. FDA)
  • Develop strong rationales for reportability decisions
  • Provide guidance to team members when assessing event reportability
  • Create or update QMS documents as needed
  • Review and make the final decision on escalated or complex complaints to determine reportability of medical complaints
  • Assist in drafting responses to inquiries from regulatory bodies, physicians, health care professionals, patients, field staff, and other departments
  • Provide training on patient physiology, anatomy, and disease state as well as cardiac pacing products
  • Review complaint files to ensure compliance with internal processes and regulatory requirements, and communicate findings to management and to team members
  • Exercise judgment in planning, organizing, performing, coordinating and/or directing work
  • Remain abreast of medical/technical advancements and communicate them to colleagues and associates
  • Exercise judgment within defined procedures and practices to determine appropriate action
  • Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations
  • Promote the process of continuous quality improvement and risk management
  • Support Health Hazard Evaluation (HHE) process
  • Identify and coordinate solutions for process improvements
  • Maintain positive and cooperative communications and collaboration with all levels of the organization and customers

    General Qualifications:

    The following are required for the Clinical Group Leader role:

    • Health Care Professional background, BSN RN strongly preferred
    • Knowledge of patient disease states related to cardiac rhythm management devices, e.g. pacemakers, ICDs, leads
    • Ability to establish/maintain good working relationships and be able to work cooperatively/productively with various business partners, e.t. engineers, vendors, customers, field clinical engineers, and
    • Ability to establish/maintain good working relationships and be able to work cooperatively/productively with engineers, vendors, customers, and Field Clinical engineers
    • Ability to leverage and/or engage others to accomplish projects
    • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
    • Multitask, prioritize, and meet deadlines in a timely manner
    • Strong organizational and follow-up skills, with attention paid to detail

      Preferred:

      • Experience in the medical device industry, preferably in the cardiac pacing industry.
      • Knowledge of global regulatory reporting requirements for medical devices,
      • Knowledge of U.S. Food and Drug Administration (FDA) regulations for medical device companies, including medical device reporting (MDR)
      • Knowledge of international regulatory reporting requirements for medical device reporting, e.g. MDV, TGA
        Job Family: Engineering
        Division: ASJM Abbott St. Jude Medical
        Travel: Yes, 15 % 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)

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Postmarket Surveillance Clinical Group Lead

Abbott
Los Angeles, CA

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