Job Details

Senior Counsel Regulatory

Company name

Abbott

Organization Type

In-House

Job Type

Attorney

Date Last Verified

Feb 12,2019

Valid Through

May 28,2019

Posted on

Dec 26,2017

Years of Experience

Min 7 yrs required

Location

Santa Clara, CA, United States

Employment Type

Full-time

Industry

Legal
Practice Area
Health Care >> Health Care
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Senior Counsel, Regulatory
The candidate will be responsible for counseling on FDA laws, regulations, and guidance documents with respect to complex regulatory issues relating to the development, approval, and marketing of medical devices; product cybersecurity; lifecycle management; as well as inspectional and product safety/quality issues. Collaborates with cross-functional teams and counsels a variety of clients across Abbott’s medical device businesses on moderately complex legal regulatory issues, such as: product design and validation, product submissions, product field actions, patient complaints, 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 affect the regulation of firm’s medical devices, and identifies opportunities to influence content and engages in external influencing efforts. Interacts 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 project to ensure the work, strategy and costs meet Abbott’s expectations. Conducts regulatory due diligence in connection with any potential medical device acquisition activities. Advises legal department managers of critical project developments in a timely manner. Executes core job responsibilities in a timely manner. Assigned matters may have a moderate impact on business activities and operations. Advises Managers, Directors, General Managers and Division Vice Presidents. Must have Juris Doctor degree. Should have 7+ years of experience and demonstrated expertise in providing legal counsel on medical device regulatory and quality matters with a major corporation or law firm. Prior cybersecurity expertise or government experience is preferred. Demonstrated ability to manage attorneys and/or paralegals, and to perform successfully in cross-functional teams, with the ability to lead and mentor is needed. Ability to handle multiple projects in fast-paced environment and exercise sound commercial and legal judgment is must.

Additional info

JOB ID: 30873233

Company info

Hiring Coordinator
Abbott
Abbott Hematology Diagnostics Division
5440 Patrick Henry Drive
Santa Clara, CA 95054

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