Senior Associate General Counsel Healthcare Law at Intuitive

Position SummaryReporting to the Chief Legal Officer this attorney will bring exceptional regulatory and healthcare law experience in the life sciences addition to providing business-centric legal advice the right candidate will develop manage and execute comprehensive regulatory strategies for the Companys portfolio of products.The Senior Associate General Counsel provides counsel to the Companys 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 Companys 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 Companys Quality Compliance and business teams.Duties and ResponsibilitiesProvide day-to-day strategic and business-focused legal and risk counseling for the Companys 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 teamsAttend Product Investigation Report (PIR) meetings and serve as voting member of PIR Board to determine required actionsAssist in the review and approval of Field Action strategy and customer communicationsAssist in strategizing drafting and reviewing written responses to global regulatory bodiesParticipate in meetings with FDA and other global regulatory bodies as appropriateMonitor 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 RequirementsJuris 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 Companys 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 appropriateSupport 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 complianceAdditional RequirementsCollaborative 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 NoticesU.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 governments 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 employeesstart 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.Remote Work : NoEmployment Type : Full-time Key Skills General Counsel,Legal Case Management,Legal Drafting,Litigation,Intellectual Property Law,Legal Counsel,Legal Research,Securities Law,Employment & Labor Law,Real Estate Law,negotiation,Contracts Experience: years Vacancy: 1