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, 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.

12+ years of experience as a practicing attorney in healthcare law, 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 support and timely updates and information sharing.

Review relevant draft scientific publications and provide guidance as appropriate

Support the conduct of internal audits and investigations to assess adherence to regulatory requirements.

Identify and evaluate legal and business risks and opportunities for a healthcare company.

Draft and review complex legal documents, including regulatory filings, policies, and compliance protocols.

Conduct legal research and analysis on FDA and related regulations, policies, and industry trends Build and maintain strong relationships by providing sound legal advice on FDA-related matters.

Manage outside counsel engaged to support complex or specialized matters.

Advise on FDA regulatory matters, including product approvals (e.g. 510(k)), labeling, advertising, marketing, complaint handling, recalls, field actions, promotional reviews, and other post-market compliance.

Support and, as appropriate, participate in or lead interactions with regulatory agencies, including responding to FDA inquiries or inspections, submitting regulatory filings, and participating in meetings or negotiations.

Support control gap assessment and remediation relating to global healthcare law compliance

Additional Requirements

Collaborative, resourceful and able to anticipate needs and navigate in a rapidly changing environment.

Creative and strategic thinking; agile and flexible.

Exceptional organizational skills, problem-solving abilities, and attention to detail.

Ability to manage multiple tasks simultaneously within a rapidly changing environment.

A collaborative mindset that is open to giving and receiving ideas, perspectives, and feedback working with a wide range of individuals and audiences.

A strong sense of purpose and drive to develop high impact solutions.

Outstanding oral, written, and interpersonal communication skills.

Ability to develop and implement cross-functional processes and work collaboratively with team members.

Outgoing yet humble with a "client first" orientation.

Additional Information

Due to the nature of our business and the role, please note that Intuitive and / or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer : In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note : the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note : typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and / or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target compensation ranges are listed.

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