Senior Counsel, Regulatory

Abbott Laboratories • Chicago, IL

2d • $149,300 - $298,700 • Hybrid

About The Position

Abbott is seeking a Senior Counsel in its global Legal Regulatory and Compliance department. This role will support Abbott’s businesses on legal topics related to the regulation of Abbott’s product offerings, covering areas from product development and submissions to manufacturing, quality, product cybersecurity, and marketing practices. This is an individual contributor position reporting to Abbott’s Division Counsel, Regulatory. The preferred locations for this role are Abbott Park, IL, or Chicago, IL, with a possibility of being based in Washington DC.

Requirements

• Juris Doctor degree from an accredited law school; strong academic background.
• Admitted to a U.S. state bar in good standing; appropriate licensure to practice law.
• 7+ years of experience and demonstrated expertise in providing legal counsel on medical device and/or diagnostic regulatory and quality matters with a major corporation or law firm.
• 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.

Nice To Haves

• Scientific or technical degree
• Device cybersecurity proficiency
• Government experience
• 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

Responsibilities

• Responsible for counseling on FDA and state laws, regulations, and guidance documents with respect to complex regulatory issues relating to the development, approval, and marketing of medical devices, diagnostic testing products, and laboratory-developed tests (LDTs); inspectional and product safety/quality issues; product packaging regulations; product cybersecurity; product artificial intelligence (AI); and lifecycle management.
• 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 and post-market surveillance, 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 engage 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 projects to ensure the work, strategy, and costs meet Abbott’s expectations.
• Conducts regulatory due diligence in connection with potential M&A or other business transactions.
• 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.

Benefits

• Career development with an international company where you can grow the career you dream of
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree