Sr Director Global Regulatory Intelligence - Medical Devices

Intuitive • Sunnyvale, CA

242d

About The Position

The 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.

Requirements

• Expert knowledge of applicable rules, regulations, and guidance related to premarket submissions.
• Expert knowledge of QSR.
• Knowledge of technical standards and their use, e.g., IEC, ISO.
• Ability to effectively interact directly with regulators.
• Ability to build consensus and negotiate favorable positions.
• RAC certification is a plus.
• Minimum of 10+ years relevant experience within the total product lifecycle of medical devices.
• Expertise interacting with regulatory agencies.
• Proven track record of effective collaboration with regulatory agencies.
• Expert knowledge of applicable regulatory requirements.
• Capability of building strong relationships with internal and global partners.
• High capacity to manage multiple teams and complex tasks.
• Strong verbal and written communication skills in English.
• Exceptional interpersonal skills and ability to work with cross-functional teams.
• Experience with process implementations and improvements.
• Ability to translate regulatory requirements into task-driven processes.
• Experience with external auditors or inspectors.
• Ability to quickly read, understand, write, and communicate complex technical information.
• Bachelor's degree in science, engineering, technology, or mathematics (advanced degree preferred).

Responsibilities

• Develop and expand Global Regulatory Intelligence footprint.
• Shape standards adoption and integration strategy.
• Lead cross-functional reviews and assessments for new regulations or certifications.
• Develop and drive internal regulatory clinical evidence strategies for CE marking and other regions.
• Support and oversee compliance processes with EU Medical Device Regulation (EU MDR).
• Manage clinical evaluation planning, PMCF processes, CEP, and new processes for real-world evidence.
• Serve as corporate point of contact for the EU Notified Body.
• Oversee product indications and management of on- and off-label uses by region.
• Drive regulatory advertising and promotion (A&P) activities.
• Manage the full scope of the A&P process globally.
• Chair the A&P committee with clinical and marketing teams.
• Create and improve the maturity and compliance of Standard Operating Procedures (SOPs).
• Liaise between in-country clinical, marketing teams, and regulatory affairs.
• Develop relationships with other intelligence groups across Intuitive.
• Prepare periodic updates for leadership and management forums.
• Compile and report process metrics and KPIs related to Veeva tool.
• Work closely with global regulatory, clinical, and compliance organizations.
• Drive intelligence and communication of emerging regulatory trends.
• Provide insights and direction to key internal stakeholders.
• Ensure business requirements are defined in relation to standards application.

Benefits

• Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree