Sr. Manager, Regulatory Affairs

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
As Senior Manager, Regulatory Affairs, you will lead and manage a team responsible for developing and executing regulatory strategies within the Multiport Business Unit. Your role includes ensuring compliance with global regulations for product lifecycle management while mentoring and retaining regulatory professionals to foster a high-performance team. You will collaborate with senior leadership to align regulatory efforts with business goals and drive improvements in regulatory processes to support Intuitive’ s innovation.

Essential Job Duties

• Lead and manage the regulatory affairs team within the Multiport Business Unit, providing strategic and technical guidance to ensure compliance with global regulatory requirements.
• Develop and execute regulatory strategies for new product introductions and modifications, overseeing submissions for the U.S., Canadian, and international markets.
• Act as the primary liaison between regulatory bodies and the company, facilitating communication to expedite submission reviews and approvals.
• Evaluate and interpret new regulations and guidelines, advising senior leadership on potential impacts and necessary compliance actions.
• Coordinate and lead the preparation of regulatory submissions, including 510(k) premarket notifications, Pre-subs, and Canadian license applications.
• Provide regulatory expertise during product development and design control, ensuring that documentation such as risk management and test reports meet regulatory standards.
• Mentor and develop regulatory affairs staff, fostering a culture of continuous improvement and professional growth within the team.
• Collaborate with cross-functional teams, including R&D, quality, and manufacturing, to align regulatory strategies with business objectives and facilitate successful project execution.
• Identify and mitigate regulatory risks, developing contingency plans to address potential compliance issues.
• Stay abreast of industry trends and regulatory changes, integrating new knowledge into strategic planning and operational practices.
• Perform other duties as required, contributing to the overall success of the regulatory affairs function.

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: $176,000 USD - $264,000 USD
Base Salary Range Region 2: $149,600 USD - $187,000 USD
Shift: Day
Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.

Qualifications

Skills, Experience, Education, & Training:

• Minimum 10 years of experience in the medical device industry, including significant experience in regulatory affairs and a proven track record in the U.S. pre-sub, 510(k) and IDE submissions.
• 3-5 years of experience as a people manager with demonstrated ability to lead, mentor, and foster a culture of continuous improvement and professional growth within a team.
• In-depth understanding of U.S. medical device regulations, EU MDR, and Health Canada regulations, coupled with strategic planning and execution of global regulatory strategies.
• Strong working knowledge of design controls, risk management, verification and validation processes, and product labeling requirements.
• Excellent verbal and written communication and presentation skills, with the ability to translate complex technical information into clear regulatory documentation and submissions.
• Strong interpersonal, negotiation, and influencing abilities, capable of engaging with senior leadership and external regulatory bodies to drive initiatives.
• Proactive in professional development and staying informed about regulatory changes, with a focus on accuracy, completeness, and driving results.

Required Education and Training

Minimum B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or Pharmacy preferred. Non-technical degrees with equivalent complex medical device experience are acceptable. Advanced degree in field of study preferred, Master’s / MBA preferred.

Preferred Skills and Experience

• RAPS Regulatory Affairs Certification (RAC) is a plus.

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 Opportunity 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.

Mandatory Notices

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

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.