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Director, Regulatory Policy & Intelligence

Company: Abbott Laboratories
Location: Santa Clara
Posted on: May 14, 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 113,000 colleagues serve people in more than 160 countries.For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it's glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ---ngersticks.WHAT YOU'LL DOThe Director, Regulatory Policy & Intelligence is responsible for identifying, anticipating and analyzing the broad range of changing or emerging regulatory policy and legislation issues that have the potential to impact Abbott Medical Device business units; and for helping to develop strategies and mitigation plans to anticipate and address such policy or legislation trends. -In this global role, the appointee will anticipate, track and assess global regulatory policy trends in the medical device environment that may drive legislation changes. - -He or she will develop and improve processes to monitor and utilize emerging regulatory policy and intelligence information, including details on key networks/influencers (such as regulatory agencies, KOLs, other influential stakeholders); and will help develop and implement strategies to mitigate business risks and to develop or optimize Abbott engagement in key areas as required. -The position requires knowledge of the external regulatory policy environment; strong leadership and analytical skills; and the ability to engage with and influence internal and external stakeholders. In his or her role as Director, Regulatory Policy & Intelligence, the appointee will interact with all groups across the organization, including Global Regulatory Services, Corporate (Public Affairs, Government Affairs, Legal and -Business Unit groups including Regulatory, Quality, Supply Chain, R&D, Commercial, providing information to help influence and manage changes to ensure no disruption to business. -The senior level of this position reflects the strategic and critical nature of the role, the need for capacity building in the area of medical device regulatory policy and intelligence network development and the level at which relationships and sensitive information must be managed within and outside of Abbott. Establish a robust process and develop a strong network to anticipate and manage Regulatory policy and intelligence trends in the external environment in line with changing business needs. -Key Areas of Work to Meet these Responsibilities Include:

  • Develop processes to optimize Abbott management of emerging/changing regulatory policy and intelligence trends and related networks or influencers. -
  • Define, implement or improve processes to establish stakeholder networks, to include KOLS, regulatory agencies, Non-governmental Organizations, competitor and other regulatory drivers in the medical device space.
  • Create & maintain process(es) to ensure new or revised regulatory requirements are assessed for impact and business units are prepared to implement the necessary changes to protect market continuity while meeting regulatory requirements in all jurisdictions where we do business.
  • Build cross functional initiatives to drive policy changes in markets and key areas of interest, including stakeholder mapping, KOL engagement plans and other initiatives.
  • Provide strategic support for the RA/RPI groups to develop, define and manage the business process for tracking and communicating information thereby building Abbott's ability to gain competitive advantage from opportunities related to emerging legislation, regulatory policy and intelligence.
  • Improve and optimize internal -understanding of emerging regulatory policy and intelligence trends and the impact of/opportunities arising from such changes on -the medical device business.
  • Engage in external leadership roles through trade associations, scientific communities or other influential groups.EDUCATION AND EXPERIENCE YOU'LL BRING
    • -Minimum requirement is degree level in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, medical field. regulatory, science or equivalent discipline. -
    • At least 8 years in a senior role is required, preferably in a regulatory/policy but may consider quality assurance, research and development/support, scientific affairs, operations, or equivalent area. -
    • Comprehensive understanding of the external medical device regulatory policy environment is preferred, with a strong understanding of stakeholder networks and regulatory policy influencers -
    • Capable of broad thinking with the ability to comprehend the impact to business of emerging and changing legislation and to anticipate potential implications such as other country reactions
    • Excellent leadership, analytical and communication skills are essential
    • Excellent understanding of external policy environment is essential. - Active external leadership experience is preferred.WHAT WE OFFERAt 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, Santa Clara , Director, Regulatory Policy & Intelligence, Executive , Santa Clara, California

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