Director Global Regulatory Affairs Digital Solutions

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

Primary Function of Position:

The Director Regulatory Affairs Digital Solutions develops and drives regulatory clearance strategies and processes for global digital solutions with a focus on digital medical devices and supporting applications.

Roles and Responsibilities:

Main activities

• Regulatory Strategy
  • Develop, implement and execute regulatory strategies that enable interconnected devices deployment in a global environment
  • Assure timely regulatory clearances for key digital solution launches in US and Canadian markets; Drive for inclusive approach to global digital regulations to support commercial strategies
  • Exercise highly complex level of independent judgment and execution directly impacting the operational results of the business unit; manage, oversee and balance resource allocation across critical projects;
• Regulatory Agencies & advocacy
  • Prepare the organization for continuous regulation changes and streamline processes to adapt to rapid product development
  • Represent Intuitive in key interactions with regulatory agencies to build a strong and trusted relationship
  • Follow-up with organizations, committees and task force meetings with the aim of developing Intuitive positions and actively contributing to achieve desired policy outcomes
  • Identify potential partners (industry, think tanks, etc.) or relevant stakeholders for Intuitive’s positions and advocacy involvement
• Process
  • Translate regulations into actionable processes and requirements
  • Identify and lead process improvement efforts
  • Ensure that company policies, procedures and practices are in compliance with applicable regulatory requirements
• People Management
  • Assesses the current state of the department (organizational structure, competencies and skills) and implement a strategic vision and tactical plans consistent with the organizational and RA strategic objectives.
  • Leverage expertise to educate and coach others on the development and execution of business plans and Regulatory Affairs strategies with a focus on innovative results
  • Identify competences and skills necessary to support regulatory strategies and company goals
  • Lead by acquiring and developing a diverse team of talented regulatory professionals and transparently communicating in a constructive manner
  • Deliver by mobilizing and inspiring an accountable team to deliver results for on-time clearances with a global and enterprise-wide mindset and balance with strategic and short-term goals

Additional activities

• Other regulatory tasks and projects may be assigned as necessary
• Travel: up to 20%

Qualifications

Required Knowledge, Skills, and Experience:

• At least 12+ years of significant experience in regulatory affairs for medical devices
• Minimum a Bachelors or Master's degree in engineering, medical technology or similar preferred (or equivalent work experience in similar function)
• Comprehensive knowledge of device development process
• Expert knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR 800+, European Medical Device Regulation (2017/745/EU)
• Knowledge of pro