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Senior Counsel, Regulatory

Abbott22h ago
United StatesOnsiteFull-timeSenior Level7+ yrs exp
H-1B sponsor

Top focus

Legal Counsel

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 115,000 colleagues serve people in more than 160 countries

Job Description

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: 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 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.

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. 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.

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.

Preferred Qualifications 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 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. 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 Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.

Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal 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.

JOB FAMILY: Operations & Business Support DIVISION: GENC General Counsel LOCATION: United States > Abbott Park : AP06A ADDITIONAL LOCATIONS: United States > Chicago : Willis Tower Building 233 S Wacker Dr., United States > Washington : 1801 Pennsylvania Ave N.W.

WORK SHIFT: Standard TRAVEL: Yes, 25 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Required skills

FDA regulationsmedical devicesdiagnostic testingregulatory complianceproduct cybersecuritylegal counsel
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