Senior Counsel,
Regulatory
We are seeking a Senior Counsel in Abbott’s global Legal
Regulatory and Compliance department, which will support Abbott’s Diagnostics
(Core, Rapid, Molecular, and Point of Care) and Diabetes Care businesses on
legal topics relating to the regulation of Abbott’s product offerings, from
product development and submissions to product cybersecurity, manufacturing and
marketing practices. This is an individual contributor position currently
reporting to Abbott’s Divisional Vice President and Associate General Counsel,
Legal Regulatory & Compliance.
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.
Core Job Responsibilities
Responsible for counseling on FDA laws, regulations, and
guidance documents with respect to complex regulatory issues relating to the
development, approval, and marketing of diagnostic testing products and certain
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 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 may impact the regulation of Abbott’s
product offerings and identifies opportunities to influence content and
engages 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 project to ensure the work, strategy and costs meet Abbott’s
expectations; and
- 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
Minimum Education
- Juris Doctor
degree from an accredited law school; strong academic background; admitted
to a US state bar in good standing; appropriate licensure to practice law.
- Scientific or
technical degree not required, but desirable
Training/Experience Required
- Generally, 7+
years of experience and demonstrated expertise in providing legal counsel
on diagnostic and/or medical device regulatory and quality matters with a
major corporation or law firm; device cybersecurity proficiency is
desirable; government experience is also beneficial.
- 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
- 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
