Director Multiport Regulatory Affairs

Primary Function of Position

This Director role leads the enterprise level Multiport Business Unit (MP-BU) Regulatory Affairs (RA) teams supporting the total product lifecycle. This role also serves as the corporate hub for global RA teams meaning assisting and coordinating OUS regulatory work with local product development teams as needed. Sr. Managers Managers or level 5 or 6 individual contributors will report to this position as needed. Professionals at this level take on the role of the strategic regulatory lead while developing new approaches for achieving or defining business objectives. Strategic planning and working with other teams throughout the product lifecycleboth within and outside the individuals organizationare among the most important responsibilities.

Essential Job Duties

• Work with executive level BU leaders to develop and execute regulatory strategies and plans.
• Obtain timely market access for new product introduction and product sustaining activities.
• Support and help to achieve corporate incentive plan (CIP) goals.
• Serve as subject matter expert for USA and Canada markets.
• Perform regulatory intelligence assessments for new or revised standards policies rules regulations and guidance.
• Support global market access through close collaboration with OUS regional counterparts.
• Build and sustain a worldclass regulatory affairs team.
• Manage departmental budgets and resources and assist in long range planning.
• Develops junior leaders and individual contributors to prepare for company growth and to develop talent
• Presents work products updates advice and key learnings at executive forums.
• Has a growth mindset and is a humble trusted inspirational and motivational leader who creates psychological safety holds high standards and takes ownership and responsibility for achieving the mission of the company.
• Is a culture champion who leads by example acts with integrity speaks truth to power puts patients first always.
• Oversee premarket regulatory submissions for USA and CA including registrations 510(k) IDE Presub serving as signature authority.
• Oversee sustaining activities including letter-to-file product changes registration renewals and approved product list changes.
• Contribute to clinical data development planning strong working knowledge of clinical study development and IDE submissions
• Maintain expert level knowledge of standards policies rules regulations and guidance related to our products
• Understands and applies international consensus standards in appropriate contexts
• Interfaces with and establishes working relationships with multiple government and nongovernment organizations impacting market access
• Leads the development and execution of good regulatory practice and policy and regulatory systems to meet organization objectives
• Analyzes links between global societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy
• Is responsible for the overall development creation and implementation of regulatory systems and procedures to support the organization and its strategic objectives.
• Influences changing regulations and guidance.
• Provides strategic input on regulatory requirements to R&D clinical leads and other executive leaders for complex and/or critical products
• Leads the regulatory teams engagement in evaluation of risk and safety issues for complex and/or critical products and recommends regulatory solutions during pre-approval/clinical phases.
• Leads and represents the regulatory team in product associated events recalls and product withdrawals
• Assess the data/ metrics/ performance etc. generated for continuous improvement opportunities within the organization and leverages such information to achieve regulatory objectives.
• Communicates regulatory and scientific issues with management and ensures management understanding of regulatory and scientific challenges
• Provides recommendations to decision makers on regulatory strategies and options on new products or claims that balance business needs with regulatory oversight.
• Interprets and translates regulatory requirements into business opportunities.
• Supports due diligence process for company by ensuring effective regulatory assessment
• Creates a culture of good information practices protection/safeguarding of information
• Understands and utilizes financial information to contribute to organizational business decisions and to make regulatory business unit decisions
• Provides strategic guidance for resource and development planning
• Reviews and approves creation and/or modification of operational infrastructures (e.g. processes systems structures roles metrics) to support strategic objectives for driving sustainable results
• Anticipates challenges develops strategies and assures implementation to resolve complex issues with potential for significant regulatory impact
• Oversees regulatory aspects of business relationships to ensure compliance and protect corporate interests.
• Identifies and proactively responds to scientific and/or clinical advances that impact healthcare product development and regulations.
• Serves as a thought leader in the understanding and application of evolving regulatory science to develop new approaches to improve the development review and oversight of healthcare products
• Champions ethical behavior by ensuring integrity in personal and organizational practices respects people and principles including professional ethical and human values. Is sensitive to the potential for implicit bias and will raise any concerns through appropriate organizational channels.
• Models encourages and creates the conditions for an inclusive and respectful work environment. Acts as a catalyst and change agent for creating an inclusive and respectful work environment.
• Ensures knowledge and lessons learned are shared across organizational boundaries. Leads thorough analysis of situations with appropriate attention to details and the big picture including consideration of impact at multiple levels of the system.
• Champions and cultivates a diverse workforce
• Communicates updates to staff to gain alignment
• Develops and implements effective communication and engagement strategies with partners.
• Makes tough or unpopular decisions where mission outcomes supersede the interests/concerns of individuals constituencies or current situation
• Builds and sustains partnership across organizational boundaries and functions as well as outside the organization to achieve common goals and outcomes.
• Monitors potential situations or incidents that may compromise individuals the regulatory function or organization and intervenes in a positive manner to resolve the issue.
• Actively leads and engages in policy development implementation and communication by framing emerging issues and contributing expertise in support of the organizations vision strategy priorities and obligations
• Makes timely and effective decisions balancing the need for more information or analysis with the need to be decisive
• Communicates the organizations regulatory position to business partners.
• Creates challenging tasks and development opportunities for employees within the organization and strives for the importance of personal development.
• Actively engages in strategic and operational talent management practices (selection promotion development and engagement) to cultivate a workforce that is well aligned with current and emerging talent needs

Qualifications :

Required Experience and Education

• Minimum 12 years of regulatory affairs experience as an individual contributor and 5-7 years as a people leader with progressive span of control. Bachelors degree in science technology engineering or mathematics (STEM). Advanced degree in a relevant field may substitute for some experience e.g. MS PhD or MBA.

Required Knowledge Skills and Abilities

• Experience leading multiple teams
• Navigates ambiguity and demonstrates agility and other executive characteristics.
• Possesses and communicates strong understanding of the requirements opportunities risks and alternatives for developing and maintaining products.
• Sets the tone for ethical standards of behavior.
• Mastery of assigned domain in regulatory requirements strategy agency negotiation and industry representation.
• Executive-level presence leadership policy and risk management skills.
• Talent development program execution and change leadership.
• Strategic and persuasive communication ability.

Physical Requirements

• Not applicable

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 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.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates qualifications consistent with applicable law.

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 :

No

Employment Type :

Full-time