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.
- 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.
- 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