Senior Counsel, Regulatory
AbbottAbbott parkUpdate time: January 21,2022
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.

We are seeking a Senior Counsel in Abbott’s global Legal Regulatory and Compliance department, which will support Abbott’s Diagnostics (Core, Rapid, Molecular, and Point of Care) and Diabetes Care businesses on legal topics relating to the regulation of Abbott’s product offerings, from product development and submissions to product cybersecurity, manufacturing and marketing practices. This is an individual contributor position currently reporting to Abbott’s Divisional Vice President and Associate General Counsel, Legal Regulatory & Compliance.

About Abbott Legal:

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 inclusive and 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. 

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 diagnostic testing products and certain medical devices; product cybersecurity; lifecycle management; as well as inspectional and product safety/quality issues.

  • Collaborates with cross-functional teams and counsels a variety of clients across Abbott’s 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 may impact the regulation of Abbott’s product offerings and identifies opportunities to influence content and engages in external influencing efforts;
  • Interacts with 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 potential M&A or other business transactions.

Position Accountability/Scope

  • Advises multiple Abbott businesses on legal regulatory matters
  • Advises Managers, Directors, General Managers, Division Vice Presidents and executive leaders
  • Advises legal department managers of significant project developments and complex legal issues
  • Helps manage departmental budget, working with Divisional Vice President and other regulatory attorneys

Minimum Education

  • Juris Doctor degree from an accredited law school; strong academic background; admitted to a US state bar in good standing; appropriate licensure to practice law.
  • Scientific or technical degree not required, but desirable

Training/Experience Required

  • Generally, 7+ years of experience and demonstrated expertise in providing legal counsel on diagnostic and/or medical device regulatory and quality matters with a major corporation or law firm; device cybersecurity proficiency is desirable; government experience is also beneficial.
  • Must have demonstrated ability to influence others, to perform successfully in cross-functional teams, and to lead, mentor and develop others
  • Must have ability to handle multiple projects in fast-paced environment and exercise sound commercial and legal judgment
  • Successful candidates are team players and servant leaders who not only possess top-notch legal skills, but display excellent interpersonal, strategic thinking, communication and organizational skills

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