Chief Global Regulatory Counsel, GE Healthcare

Lead GE Healthcare Legal on product regulation and quality, partnering with the global Quality and Regulatory Affairs organization (Q&R). This role reports to the General Counsel, Products, and will be dotted line to the Chief Quality & Regulatory Officer (CQRO). The successful candidate will be on the extended executive staff of the CQRO and will be responsible for:

providing strategic legal advice to Q&R across GE Healthcare products, and advising GE Healthcare on regulatory opportunities (e.g., pending legislation, including, but not limited to, the intersection of technology, software, artificial intelligence / machine learning, and patient care), business direction, and strategic and tactical matters.

Your Responsibilities

• Partner with Q&R to identify opportunities to drive the business forward while ensuring safety and compliance, including, but not limited to, targeted, proactive strategies to influence regulatory policy in the US and other key markets for patient benefit, as well as strategically implementing new regulatory guidance
• As a core member of the GE Healthcare Product Safety Review Board (PSRB), attend PSRB meetings and advise on recall strategy and communications; review and approve recalls and complaint closures
• Counsel on response to regulator inquiries, and audit / inspection activities and responses, working with Q&R subject matter experts, relevant business personnel, and other counsel (e.g., Litigation) as warranted
• Review advertising / promotional, investor relations, and other corporate as well as product-related communications, both external and internal, that are cross-product (i.e., content relevant to more than one product modality)
• Update Q&R-focused policies and processes as well as provide regulatory advice and training in conjunction with Regulatory and Compliance
• Consult and manage outside counsel as the need arises pertaining to Q&R activities
• Your Experience
• Juris Doctor (or ex-U.S. equivalent) with active bar membership / license
• Minimum of 10 years of healthcare regulatory legal experience, with focus on the U.S. Federal Food Drugs and Cosmetics Act, at a law firm, government agency, and / or corporate legal department
• Minimum 5 years experience working in a large global complex organization
• Prioritizing conflicting demands from multiple stakeholders in a fast-paced environment
• Identifying and resolving legal issues at pace with ability to make on-the-spot risk calls
• Leading effectively in a matrixed environment
• Operating with due discretion, confidentiality, objectivity, and independence
• Digesting and distilling large amounts of information into essential elements and presenting it with excellent command of the English language
• Team player, collaborative, humble, and transparent leader
• Excellent communication and presentation skills, interpersonal skills, mature judgment, and independent thinking, with ability to interact effectively at all levels of an organization
• Excellent analytical, process management and implementation skills, sensitivity to issues, and facilitation and problem-solving skills
• High level of cultural sensitivity, flexibility, and emotional intelligence to work effectively across a global, multicultural environment
• This position can sit anywhere in the US

Desired Characteristics

• Healthcare legal regulatory experience with other country medical device regulations (e.g., China NMPA, Europe EMA)

• Medical Device Industry experience

#LI-Remote

Additional Information

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE 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 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).

As a federal government contractor, GE may in the future be required to have U.S. employees fully vaccinated against COVID-19.  Some GE customers currently have vaccination mandates that may apply to GE employees.

Relocation Assistance Provided: No

To Apply:

https://jobs.gecareers.com/healthcare/global/en/job/GE11GLOBALR3628438EXTERNALENGLOBAL/Chief-Global-Regulatory-Counsel?utm_source=linkedin&codes=linkedin&utm_medium=phenom-feeds