JOB9899 Sr Director Global Regulatory Intelligence And Clinical Evidence Evaluation

Company: Intuitive
Location: Sunnyvale
Posted on: March 30, 2025

Job Description:

Job DescriptionThe primary function of this role is to develop and expand our Global Regulatory Intelligence footprint and prepare the organization to gather intelligence on current and future regulations. This leader will be instrumental in shaping our standards adoption and integration strategy, ensuring it meets commercial and regulatory requirements across an increasing number of global markets.This position will lead cross-functional reviews and assessments for new regulations or certifications, as well as develop and drive internal regulatory clinical evidence strategies for CE marking and other regions. The role will support and oversee processes related to compliance with the EU Medical Device Regulation (EU MDR) and beyond, including processes, procedures, quality monitoring, and escalation thresholds. It will manage clinical evaluation planning, PMCF processes, CEP, and new processes for real-world evidence to support regulatory submissions. This role will serve as the corporate point of contact for the EU Notified Body, ensuring alignment and success from a regulatory EU clearance perspective.This position oversees product indications and consolidation, as well as the management of on- and off-label uses by region.This highly visible leader will drive regulatory advertising and promotion (A&P) activities, identifying and integrating regulatory and compliance requirements to facilitate materials review, product communication, and optimization of the A&P process, while working closely with the marketing and clinical teams.This leader will continue to build out processes to deliver insights and prepare the organization to meet current and future regulatory requirements applicable to our processes and product portfolio.This position will lead cross-functional reviews and assessments for all business units and product portfolio management associated with product launch documents. The individual will have a solid understanding of the complexities of the organization's regulatory processes, critical information, and how to simplify these processes while working closely with business partners.Responsibilities:

• Act, if necessary, as EU authorized representative contact for the EMEIA HQ organization and region (according to the EU MDD and moving forward MDR) per delegation from VP Global RA and RAQA Commercial.
• Management representative when delegation provided by VP Global RA and RAQA Commercial.
• Budget responsibility development in alignment with VP Global RA and RAQA Commercial and regional leads.
• Support country commercial organization development and implementation of country-specific needs with proper teams.
• Manage the full scope of the A&P process globally and its supporting personnel, leading the A&P team related to all corporate document review related to marketing and any compliance discussion related to our product claims and intended use.
• Chair the A&P committee with the clinical and marketing team functions.
• Act as a primary source of expertise related to A&P materials within the organization reviewing all materials used for product communication or advertising.
• Create and improve the maturity and compliance of Standard Operating Procedures (SOPs), templates, forms, and logs.
• Liaise between in-country clinical, marketing teams in the Direct and Indirect QARA groups, Subject Matter Experts and Regulatory Affairs to facilitate completion of regulatory review of A&P.
• Work closely with other managers and leadership teams to better ascertain how A&P can improve 'forward looking' regulatory requirements monitoring and provide inputs to the appropriate processes.
• Develop relationships necessary to exchange data and information with other intelligence groups across Intuitive such as: GAVE, Market Intelligence, Competitive Intelligence, and others, as the need arises.
• Ensure that periodic updates are prepared as required by leadership and management forums (i.e. Quality Review Board (QRB), Regulatory Surveillance Operating Committee (RSOC), Management Review, etc.).
• Compile and report process metrics and KPIs related to Veeva tool; provide periodic process timeliness reports to help keep assessment and implementation activities on-target.
• Work closely with the global regulatory, clinical and compliance organizations to fully understand applicable standards/regulations and implement processes to ensure Intuitive achieves and maintains compliance.
• Drive intelligence and communication of emerging regulatory trends and implications to internal stakeholders.
• Provide insights and direction to key internal stakeholders including but not limited to Clinical Evaluation, Supply Chain, Master Data, Quality, Regulatory, Labeling, Marketing, and Product Development.
• Ensure business requirements are defined/captured in relationship to standards application and management within associated enterprise IT and master data architecture and design.
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