Director Multiport Regulatory Affairs

About the role

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 lifecycle-both within and outside the individual's organization-are 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 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 e

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Company Intel

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