1+ months
2018-03-152018-10-19

Senior Counsel, Regulatory

Abbott
United States

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.

Who We Are:

We are legal professionals charged with driving Abbott’s businesses forward. We engage as business leaders, beyond providing legal advice, to solve problems for the company and the customers and patients we serve. 

What we offer:

A position in the Abbott Legal Division provides an opportunity to learn and grow.  As our company grows and evolves, so do our roles. We engage in meaningful, challenging, and interesting work on a global scale. This continual evolution provides experiences and opportunities to grow both in the depth of legal expertise as well as breadth of leadership.

How we work:

We value diversity of backgrounds and experiences in our teams. This is integral to our collaborative environment.  We expect and encourage our employees to be holistic thinkers and we are expected to see the big picture and impact of our advice.  

Employer of Choice:

Through numerous local, national and international accolades, Abbott is regarded as an employer of choice for our commitment to workplace excellence.  Our employees are given the tools to succeed, lead and grow, with challenging opportunities and work that makes a difference.  Through our diverse healthcare businesses, we connect people and potential in ways that no other company can.  Discover a world of opportunities at Abbott.

Core Job Responsibilities

Responsible for counseling on FDA laws, regulations, and guidance documents with respect to complex regulatory issues relating to the development, approval, and marketing of medical devices; product cybersecurity; lifecycle management; as well as inspectional and product safety/quality issues.

Senior Counsel, Regulatory is an intermediate individual contributor position for lawyers in Abbott’s Legal Division.  Senior Counsel, Regulatory:

  • Collaborates with cross-functional teams and counsels a variety of clients across Abbott’s medical device businesses on moderately complex legal regulatory issues, such as: product design and validation, product submissions, product field actions, patient complaints, agency inspections, advertising and promotion, and manufacturing requirements;
  • Resolves routine and moderately complex to complex legal regulatory matters with minimal supervision;
  • Keeps abreast of changes in laws and regulations that affect the regulation of Abbott’s medical devices, and identifies opportunities to influence content and engages in external influencing efforts;
  • Interacts and provides legal and strategic guidance to senior management and functional organizational leadership;
  • Helps select and directs the work of outside counsel, defines project objectives and manages project to ensure the work, strategy and costs meet Abbott’s expectations; and
  • Conducts regulatory due diligence in connection with any potential medical device acquisition activities.

    Position Accountability/Scope

    • Advises legal department managers of critical project developments in a timely manner.
    • Executes core job responsibilities in a timely manner.
    • Assigned matters may have a moderate impact on business activities and operations.
    • Advises Managers, Directors, General Managers and Division Vice Presidents.
    • No direct department budget responsibility; must however operate within budget.  Develops budgets for assigned legal matters with supervision from more experienced attorneys.

      Minimum Education

      • Juris Doctor degree

        Training/Experience Required

        • Generally 7+ years of experience and demonstrated expertise in providing legal counsel on medical device regulatory and quality matters with a major corporation or law firm; prior cybersecurity expertise or government experience is also beneficial
        • Must have demonstrated ability to manage attorneys and/or paralegals, and to perform successfully in cross-functional teams, with the ability to lead and mentor
        • Must have ability to handle multiple projects in fast-paced environment and exercise sound commercial and legal judgment
        • In addition to top-notch legal skills, must have excellent interpersonal, strategic thinking, communication and organizational skills
          Job Family: Operations & Business Support
          Division: ASJM Abbott St. Jude Medical
          Additional Location: United States - California - Sylmar
          Travel: Yes, 25 % of the Time
          Medical Surveillance: No
          Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Senior Counsel, Regulatory

Abbott
United States

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