JOB9899 Sr Director Global Regulatory Intelligence And Clinical Evidence Evaluation

Company Description

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.

Job Description

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.

by the VP Global RA and RAQA Commercial
o    Act, if necessary, as:
o    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
o    Management representative when delegation provided by VP Global RA and RAQA Commercial
o    Budget responsibility development in alignment with VP Global RA and RAQA Commercial and regional leads 
o    Could support country commercial organization development and implementation of country specific needs with proper teams 

Advertising and Promotion (A&P): 
o    Manage the full scope of the A&P process globally and it’s 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. 
o    Chair the A&P committee with the clinical and marketing team functions. 
o    Act as a primary source of expertise related to A&P materials within the organization reviewing all materials used for product communication or advertising.
o    Create and improve the maturity and compliance of Standard Operating Procedures (SOPs