Sr Director Global Regulatory Intelligence - Medical Devices

Intuitive • Sunnyvale, CA

233d • $247,000 - $370,600 • Onsite

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.

Requirements

• Expert knowledge of applicable rules, regulations, and guidance related to premarket submissions, including clinical studies.
• 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.
• Exceptional interpersonal skills and ability to work well with cross-functional teams.
• Bachelor's degree in science, engineering, technology, or mathematics (advanced degree preferred).

Nice To Haves

• Experience working with professional or trade associations regionally and by country.
• Experience and application of process implementations and improvements.
• Ability to quickly read, understand, write, and communicate complex technical and medical information.

Responsibilities

• Develop and expand Global Regulatory Intelligence footprint.
• Lead cross-functional reviews and assessments for new regulations or certifications.
• Drive internal regulatory clinical evidence strategies for CE marking and other regions.
• Oversee compliance processes with EU Medical Device Regulation (EU MDR).
• Manage clinical evaluation planning, PMCF processes, CEP, and real-world evidence processes.
• Serve as corporate point of contact for the EU Notified Body.
• 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 Standard Operating Procedures (SOPs), templates, forms, and logs.
• 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.
• Drive intelligence and communication of emerging regulatory trends.
• Provide insights and direction to key internal stakeholders.

Benefits

• Market-competitive compensation packages, including 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