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Senior Manager, Regulatory Compliance

Company: Abbott Laboratories
Location: Saint Paul
Posted on: January 15, 2022

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.Senior Manager, Regulatory Compliance - 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 Senior Manager, Regulatory Compliance to join our team in the St. Paul, MN location. - In this role, you will manage the compliance function division wide, ensure that processes and staffing are appropriately developed and implemented to maintain the quality system, participate in establishing strategic vision/goals in alignment with site organization and division, ensure compliance within organization to all applicable internal requirements and external regulations, and establishes/maintains quality system. You will also be responsible for interpreting and recommending modifications to companywide policies and practices, interfacing with outside regulatory agencies, identification, correction and prevention of compliance issues, and support the quality system. RESPONSIBILITIES:

  • Facilitates inspections of the business unit by outside Regulatory Agencies, including any required responses
  • Communicates to Management the compliance status of the division's quality system
  • Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc)
  • Makes decisions regarding work processes or operational plans and schedules in order to achieve compliance objectives for the division
  • Recruits, coaches and develops organizational talent
  • Develops, monitors and appropriately adjusts the annual budget for department(s)
  • Communicates to Management the compliance status of the business units quality system
  • Facilitates inspections of the business unit by outside Regulatory Agencies, including any required responses
  • Leads organization responsible for quality support activities including those activities associated with identification and resolution of key product and process performance issues, often through the CAPA system
  • Responsible for managing/performing regulatory change impact assessment of new regulations and technical standards - EDUCATION AND EXPERIENCE YOU'LL BRING -Required:
    • Bachelor's Degree in Engineering, Sciences, or related discipline
    • 10+ years of related work experience in a similar role within a regulated industry (i.e. medical device, Pharmaceutical, Aerospace, etc), including quality management system (QMS) experience, and/or experience with regulatory audits and certification management
    • 1+ years in a leadership/direct supervision role
    • Demonstrated experience building strategic partnerships to further departmental and organizational objectives
    • 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
      • Medical device experience
      • 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 Twitter @AbbottNews and @AbbottGlobal

Keywords: Abbott Laboratories, St. Paul , Senior Manager, Regulatory Compliance, Executive , Saint Paul, Minnesota

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