Director Global Regulatory Affairs Digital Solutions

Director Global Regulatory Affairs Digital Solutions

Requirements

• 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
• Excellent knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR 800+, European Medical Device Regulation (2017/745/EU)
• Knowledge of product regulations (eg wireless, electronical safety, ROHS…)
• Senior leadership experience is required, including line management of multiple levels of reporting.
• Exceptional cogent skills and problem-solving ability including the ability to make complex recommendations and willingness to justify difficult position.
• Demonstrate good relational skills, ability to work with others in international team environment, effective interactions in cross department teams.
• Ability to manage and influence project teams, committees, etc. to meet project goals and to drive changes.
• Ability to be effective in complex projects with ambiguity and/or rapid change
• Fluent in written and spoken English
• General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)

Responsibilities

• 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 help commercial strategies
• Exercise highly complex level of autonomous judgment and execution directly impacting the operational results of the business unit; manage, oversee and manage resource allocation across critical projects
• Prepare the organization for continuous regulation changes and streamline processes to adjust to rapid product development
• Represent Intuitive in key interactions with regulatory agencies to build an effective and credible relationship
• Follow-up with organizations, committees and task force meetings with the aim of developing Intuitive positions and effectively contributing to achieve desired policy outcomes
• Identify potential partners (industry, think tanks, etc.) or relevant stakeholders for Intuitive’s positions and advocacy involvement
• Translate regulations into actionable processes and requirements
• Identify and drive process improvement efforts
• Ensure that company policies, procedures and practices are in compliance with applicable regulatory requirements
• Assess 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 goals.
• 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 help regulatory strategies and company goals
• Manage 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 manage with strategic and short-term goals
• Other regulatory tasks and projects may be assigned as necessary

Preferred Qualifications

• RAC certification is a plus
• Experience with digital technologies
• Experience with novel technologies (AI and machine learning)
• Experience working with professional or trade associations