Senior Associate General Counsel - Healthcare Law

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

Position Summary

Reporting to the Chief Legal Officer, this attorney will bring exceptional regulatory and healthcare law experience in the life sciences industry. In addition to providing business-centric legal advice, the right candidate will develop, manage, and execute comprehensive regulatory strategies for the Company’s portfolio of products.

The Senior Associate General Counsel provides counsel to the Company’s business and functional leaders regarding applicable requirements of US Food and Drug Administration (FDA) regulations and related regulatory requirements. Reporting to the Chief Legal Officer, this attorney will be responsible for oversight of all legal aspects of the Company's FDA compliance and will provide support for other matters related to healthcare regulatory requirements, collaborating closely within the Legal team and cross-functionally with the Company's Quality, Compliance, and business teams.

Duties and Responsibilities

• Provide day-to-day strategic and business-focused legal and risk counseling for the Company’s products/product candidates, from research through commercialization, including advising on a broad range of healthcare regulatory matters, including regulatory labeling discussions, advertising and promotion, safety, market research, scientific exchange, and interactions with healthcare professionals and patients.
• Primary in-house legal point of contact for our regulatory, compliance and quality teams
• Attend Product Investigation Report (PIR) meetings and serve as voting member of PIR Board to determine required actions
• Assist in the review and approval of Field Action strategy and customer communications
• Assist in strategizing, drafting and reviewing written responses to global regulatory bodies
• Participate in meetings with FDA and other global regulatory bodies, as appropriate
• Monitor, provide input to and communicate new or emerging requirements/trends in healthcare law and regulations 
• Advise our Comparative Medicine team and serve as Institutional Officer on our IACUC (Institutional Animal Care and Use Committee)

Qualifications

Skill/Job Requirements

• Juris Doctorate degree and a member of the California State Bar or otherwise qualified to practice law in California as registered in-house counsel.
• 10+ years of experience as a practicing attorney in patent prosecution, preferably with a mix of in-house and private practice experience.
• Assist with due diligence for transactions, mergers, and securities offerings involving FDA or similar regulatory entities globally.
• Help develop and implement regulatory strategies to support the Company's business objectives while ensuring legal compliance.
• Provide guidance on global regulatory issues in coordination with international legal and regulatory teams.
• Support management of healthcare-related litigation and compliance issues as they arise.
• Provide guidance on data disclosures related to clinical development milestones through press releases, scientific exchanges, and presentations at U.S. and international medical congresses.
• Liaise with other Law Department functions both in the US and globally, including litigation, IP, Compliance, and others, to ensure integrated legal supp