Senior Counsel, Regulatory

8 - 10 years experience  • 

Salary depends on experience
Posted on 05/21/18
Alameda, CA
8 - 10 years experience
Salary depends on experience
Posted on 05/21/18

JOB DESCRIPTION:

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.

Senior Counsel, Regulatory is an intermediate individual contributor position for lawyers in Abbott’s Legal Division.  Senior Counsel, Regulatory:

  • 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 Abbott’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; and
  • Conducts regulatory due diligence in connection with any potential medical device acquisition activities.

Position Accountability/Scope

  • 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.
  • No direct department budget responsibility; must however operate within budget.  Develops budgets for assigned legal matters with supervision from more experienced attorneys.

Minimum Education

  • Juris Doctor degree

Training/Experience Required

  • Generally 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 also beneficial
  • Must have demonstrated ability to manage attorneys and/or paralegals, and to perform successfully in cross-functional teams, with the ability to lead and mentor
  • Must have ability to handle multiple projects in fast-paced environment and exercise sound commercial and legal judgment
  • In addition to top-notch legal skills, must have excellent interpersonal, strategic thinking, communication and organizational skills

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