1+ months

Manager Regulatory Affairs

Pleasanton, 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.

This position is responsible for planning, creating and implementing global solutions for regulatory approvals of products, and for managing direct reports. Applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of key business programs.

Job Duties :

  • Manages the Regulatory Affairs function for a significant business segment.
  • Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
  • Develops global regulatory strategies for new and modified medical devices.
  • Provides Regulatory leadership to development teams, e.g., global regulatory strategies and cross functional alignment with issues of possible Regulatory ramifications and mentoring junior regulatory staff.
  • Acts as a liaison with other departments, e.g., Quality, R&D, Legal, Operations, Marketing and Clinical Affairs, for major initiatives.
  • Provides technical guidance and training to RA staff:
    • during strategy formulation, submission preparation and development of labeling, marketing or promotional materials and in
    • training on departmental policies and procedures, new FDA guidance documents, and FDA warning letters, competitor updates.
    • Prepares submissions for new devices and device or manufacturing changes.
    • Reviews product and manufacturing changes for compliance with applicable regulations (Change Control).
    • Reviews protocols and reports to support regulatory compliance and submissions.
    • Reviews device labeling and advertising materials for compliance with FDA submissions and applicable regulations. 
    • Builds partnerships and mutual respect with regulatory authorities (e.g., FDA, Notified Body).
      • Support all Company initiatives as identified by 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) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
      • Performs other related duties and responsibilities, on occasion, as assigned.

        General Qualifications

        • Bachelor’s degree (BS, BA) (technical discipline preferred) with at least 8 years technical experience.
        • Minimum six years medical device regulatory experience, with minimum of 2 years managing direct reports.
        • Extensive experience with US and global medical device regulations and submissions.
        • Prior experience in the device cardiopulmonary industry a plus.
          • Experience working in a broader enterprise/cross division business unit model preferred.
          • Ability to work in a highly matrixed and geographically diverse business environment.
          • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. 
            • Ability to work effectively within a team in a fast-paced changing environment.
            • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
            • Multi-tasks, prioritizes and meets deadlines in timely manner.
            • Strong organizational, planning, and follow-up skills and ability to hold others accountable.
            • Ability to travel approximately 20%, including internationally.
            • Ability to maintain regular and predictable attendance.

              Job Family: Regulatory Operations
              Division: CAHF Cardiac Arrhythmias & Heart Failure
              Travel: Yes, 20 % 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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Manager Regulatory Affairs

Pleasanton, CA

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Pleasanton, CA

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