Senior Counsel - Health & Life Sciences Legal

Overview

This role involves serving as Senior Counsel on the Health and Life Sciences Legal and Compliance Team, focusing on medical device regulatory issues and related legal matters such as government investigations and litigation risk. The position requires expertise in software as a medical device regulation and the evolving laws governing Artificial Intelligence, particularly where they intersect. The attorney will primarily support Health & Life Sciences business units but will also collaborate with other units selling products to this sector. The role demands strategic, collaborative, and creative problem-solving skills to navigate a fast-paced software development and regulatory environment.

Responsibilities

• Lead counsel on medical device legal regulatory issues affecting customers' use of products in the US, Canada, and Latin America, with emphasis on software as a medical device, AI/ML, real world data, and precision medicine.
• Advise on regulatory standards for product qualification and classification.
• Provide guidance on regulatory and compliance implications and market standard terms for commercial transactions.
• Collaborate cross-functionally to advance regulatory and compliance program goals.
• Participate in initiatives to improve business operations and facilitate efficient commercial transactions.
• Advise on changing regulatory requirements in the US, Canada, and Latin America impacting business, regulatory affairs, and quality/compliance programs.
• Contribute to policy initiatives in health and life sciences regulatory areas domestically and internationally.

Requirements

• Juris Doctor (JD) degree with 10+ years of legal experience in the software as a medical device industry.
• Expertise as regulatory counsel at the intersection of technology, life sciences, and healthcare.
• Knowledge of laws governing software as a medical device, AI/ML software, clinical research, real world data, and related topics.
• Experience advising on software clinical decision support products regarding medical device qualification or enforcement discretion.
• Experience reviewing commercial transactions in health and life sciences, especially involving advanced technology.
• Professional demeanor with confidence and innovation; ability to counsel senior executives and clients effectively.
• Excellent writing, communication, analytical, negotiation, and partnership skills.
• Strong problem-solving skills with creativity and sound decision-making.
• Outstanding project management and interpersonal abilities.
• Exceptional business orientation balancing legal considerations with commercial priorities.
• Ability to perform in a fast-paced, evolving business environment.

Compensation & Benefits

• Salary range in the US: $126,200 - $264,100 per year.
• Eligibility for bonus, equity, and compensation deferral.
• Comprehensive benefits package including:
  • Medical, dental, and vision insurance with expert medical opinion.
  • Short-term and long-term disability coverage.
  • Life insurance and accidental death & dismemberment insurance.
  • Supplemental life insurance options for employee, spouse, and child.
  • Health care and dependent care Flexible Spending Accounts.
  • Pre-tax commuter and parking benefits.
  • 401(k) Savings and Investment Plan with company match.
  • Paid time off: Flexible vacation for salaried employees; accrued vacation for others, with accrual rates based on hours worked and tenure.
  • 11 paid holidays.
  • Paid sick leave: 72 hours upon hire, refreshing annually with carryover up to 112 hours.
  • Paid parental leave.
  • Adoption assistance.
  • Employee Stock Purchase Plan.
  • Financial planning and group legal services.
  • Voluntary benefits including auto, homeowner, and pet insurance.

Location

• US-based role with responsibilities covering the US, Canada, and Latin America.

Additional Information

• Certain US-based or US customer/client-facing roles may require compliance with immunization/occupational health mandates and/or drug testing.
• The role is classified as Career Level IC4.
• The employer is an Equal Employment Opportunity organization committed to inclusive hiring practices and providing accommodations for disabilities throughout the employment process.