Senior Counsel, Regulatory
$149,300–$298,700 year
On-siteChicago, Illinois, United States or Washington, District of Columbia, United States
Job Summary
Counsel Abbott's global Regulatory and Compliance department on FDA and state laws regarding medical device development, approvals, marketing, and product cybersecurity. Resolve routine to complex legal regulatory matters involving product submissions, field actions, agency inspections, and manufacturing requirements while collaborating with cross-functional teams. Manage outside counsel, direct project objectives, and conduct regulatory due diligence for potential M&A transactions. Advise senior management and functional leaders on significant legal issues, influence external regulatory efforts, and help manage the departmental budget.
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
- ability to perform successfully in cross-functional teams
- ability to lead, mentor, and develop others
- ability to handle multiple projects in fast-paced environment
- sound commercial and legal judgment
- Must be based in Abbott Park, IL or Chicago, IL
- May consider role to be based in Washington DC
- Must be available for 25% travel
Desired Qualifications
- Scientific or technical degree
- Device cybersecurity proficiency
- Government experience
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