Senior Counsel, Regulatory

Abbott • Chicago, DC

16h • 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 with a strong academic background.
• Admitted to a U.S. state bar in good standing and 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.
• Demonstrated ability to influence others.
• Demonstrated ability to perform successfully in cross-functional teams.
• Demonstrated ability to lead, mentor, and develop others.
• Ability to handle multiple projects in a fast-paced environment.
• Ability to exercise sound commercial and legal judgment.

Nice To Haves

• Scientific or technical degree.
• Device cybersecurity proficiency.
• Government experience.
• Team player and servant leader with excellent interpersonal, strategic thinking, communication, and organizational skills.

Responsibilities

• Counseling on FDA and state laws, regulations, and guidance documents concerning complex regulatory issues for medical devices, diagnostic testing products, and laboratory-developed tests (LDTs).
• Addressing inspectional and product safety/quality issues, product packaging regulations, product cybersecurity, product artificial intelligence (AI), and lifecycle management.
• Collaborating with cross-functional teams and advising various Abbott businesses on legal regulatory matters such as product design, validation, submissions, field actions, patient complaints, post-market surveillance, agency inspections, advertising, promotion, and manufacturing requirements.
• Resolving routine and complex legal regulatory matters with minimal supervision.
• Staying updated on changes in laws and regulations impacting Abbott’s product offerings and identifying opportunities for external influencing efforts.
• Interacting with and providing legal and strategic guidance to senior management and functional organizational leadership.
• Assisting in the selection and direction of outside counsel, defining project objectives, and managing projects to meet Abbott’s expectations regarding work, strategy, and costs.
• Conducting regulatory due diligence for potential mergers, acquisitions, or other business transactions.
• Advising multiple Abbott businesses on legal regulatory matters.
• Advising Managers, Directors, General Managers, Division Vice Presidents, and executive leaders.
• Informing legal department managers of significant project developments and complex legal issues.
• Assisting in managing the departmental budget in collaboration with the Divisional Vice President and other regulatory attorneys.

Benefits

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
• Excellent retirement savings plan with high employer contribution
• Tuition reimbursement
• Freedom 2 Save student debt program
• FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree

What This Job Offers

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