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Intuitive · 1 day ago

Senior Associate General Counsel - Healthcare Law

Sunnyvale, CA

Full-time

Onsite

Senior Level, Lead/Staff

$292K/yr - $438K/yr

12+ years exp

Intuitive is a pioneer in robotic-assisted surgery, focused on advancing minimally invasive care. The Senior Associate General Counsel will provide strategic legal counsel on healthcare regulatory matters, ensuring compliance with FDA regulations and supporting the company's product portfolio.

Health CareManufacturingMedical Device

Growth Opportunities

H1B Sponsor Likely

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)

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

Qualification

Healthcare law experienceFDA complianceRegulatory strategiesLegal researchJuris DoctorateCalifornia State BarHealthcare litigationComplex legal documentsInterpersonal communicationProblem-solvingOrganizational skillsCollaborative mindset

Required

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