Director Multiport Regulatory Affairs

Intuitive•Sunnyvale, CA

About The 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 lifecycle—both within and outside the individual’s organization—are among the most important responsibilities.

Requirements

Minimum 12 years of regulatory affairs experience as an individual contributor and 5-7 years as a people leader with progressive span of control.
Bachelor’s 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.
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.

Responsibilities

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 team’s 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 organization's 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 organization's 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