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 product regulations (eg wireless, electronical safety, ROHS…)
- Senior leadership experience is required, including line management of multiple levels of reporting.
- Strong analytical skills and problem-solving ability including the ability to make complex decisions and willingness to defend difficult position.
- Demonstrate good interpersonal skills, ability to work with others in international team environment, effective interactions in cross department teams.
- Ability to lead 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)
Preferred Knowledge, Skills, and Experience:
- RAC certification is a plus
- Experience with digital technologies
- Experience with novel technologies (AI and machine learning)
- Experience working with professional or trade associations
Additional Information
Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Employment Opportunity / Affirmative Action Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
Base Salary Range Region 1: $208,500 USD - $312,700 USD
Base Salary Range Region 2: $177,200 USD - $265,800 USD
Shift: Day
Travel: 25% of the time
Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.
