Job Details
Job Description Summary
The Senior Counsel, Regulatory will be responsible for providing strategic legal support regarding global quality and regulatory matters associated with manufacturing, distribution, and sale of medical devices and pharmaceuticals. The Senior Counsel, Regulatory will work closely with global Quality and Regulatory partners, Legal and Compliance partners, and other cross-functional partners to facilitate GE HealthCare s vision and strategy, support regulatory compliance, and mitigate risk. This role will include advising on a wide array of quality and regulatory topics across GE HealthCare products, businesses, and regions. Particular areas of focus will include pharmaceutical regulation, advertising and promotion, and business development initiatives. This role could be located anywhere within the U.S.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Job Description
Essential Responsibilities:
The Senior Counsel, Regulatory will be part of a small Global Legal-Regulatory team providing counsel to the GE HealthCare Quality and Regulatory Organization.
Responsibilities for the role of Senior Counsel, Regulatory will include:
Provide legal guidance regarding FDA regulations and other global regulations relating to pharmaceutical and medical device products, including pre-market and post-market quality and regulatory requirements.
Advise as needed on FDA regulations and other global regulatory requirements in the context of business development activities.
Advise on advertising and promotion matters related to pharmaceuticals and medical devices.Work collectively with Regulatory, Legal and Compliance colleagues in the development and implementation of policies, procedures, legal guidance documents, and training materials in certain key areas of regulation including advertising and promotion materials and other external communications.
Engage with cross-functional colleagues, including Quality & Regulatory, to identify and advise in areas of new and emerging law related to regulation of medical device and pharmaceutical products.
Partner with Quality & Regulatory colleagues to help develop and finalize responses to audit / inspection findings.
Assist in due diligence of GEHC potential acquisitions and potential remediation/integration activities after acquisition.
Qualifications/Requirements:
Juris Doctor (or Ex-US equivalent) with active bar membership/license.
5 or more years of healthcare regulatory legal experience, with focus on U.S. Federal Food, Drug, and Cosmetic Act at a large law firm, government agency, and/or corporate legal department, including focus on pharmaceutical regulations.
Desired Characteristics:
A strong commitment to integrity and professionalism, solid judgment and a passion for excellence.
Strong analytical skills and verbal/written communication skills.
Ability to provide thoughtful and clear counsel to a variety of stakeholders on complex matters of law and regulation, distilling high-volume and complex information into salient and relevant points.
Effective interpersonal skills, mature judgment, and independent thinking, with ability to interact across functions and at all levels of an organization with clarity, objectivity, candor, and transparency.
Ability to identify and resolve legal issues in a fast-paced environment.
Willingness to work collaboratively with a high degree of engagement and contribution.
Ability to prioritize while managing conflicting demands from multiple stakeholders.
Problem-solving mindset.
High level of cultural sensitivity, flexibility, and emotional intelligence to work effectively across a global, multicultural environment.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you d expect from an organization with global strength and scale, and you ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.
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For U.S. based positions only, the pay range for this position is $168,960.00-$253,440.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.
Additional Information
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer ( . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No