Senior Counsel, Regulatory

The Opportunity

We are seeking a Senior Counsel in Abbott’s global Legal Regulatory and Compliance department, which will support Abbott’s businesses on legal topics relating to the regulation of Abbott’s product offerings, from product development and submissions to manufacturing and quality, product cybersecurity, and marketing practices.

This is an individual contributor position reporting to Abbott’s Division Counsel, Regulatory. Preference for the role is to be based in Abbott Park, IL or Chicago, IL. May consider role to be based in Washington DC.

What You’ll Work On

• 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.
• Solves 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 direct 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.

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.

Required Qualifications

• 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.
• Demonstrated ability to influence others, to perform successfully in cross-functional teams, and to lead, mentor, and develop others.
• Ability to handle multiple projects in fast-paced environment and exercise sound commercial and legal judgment.

Preferred Qualifications

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

About Abbott Legal

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.
• Achieve meaningful, challenging, and interesting work on a global scale.
• Challenging opportunities and work that makes a difference.

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.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives : www.abbottbenefits.com

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Pay Range

The base pay for this position is $149,300.00 – $298,700.00. In specific locations, the pay range may vary from the range posted.