Regulatory Operations Intern

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.

Primary Function of Position

• Work cross functionally with different departments to assist in process improvements and develop a broad knowledge of the medical device industry.
• Help drafting and reviewing technical documentation for medical devices.
• Help archiving 510k submissions, including queries received from FDA.
• Assess regulatory documentation impact of a newly published/updated guidance or regulation.
• Manage registration data to ensure global compliance for product release.
• Utilize global regulatory standards to ensure compliance of regulatory documentation.
• Assist with process management of international change notifications.
• Work on team process improvements under the guidance of Regulatory Operations Team.

Essential Job Duties

• Work cross functionally with different departments to assist in process improvements and develop a broad knowledge of the medical device industry.
• Successfully communicate with global teams on new processes and other department initiatives.
• Work on team process improvements under the guidance of Regulatory Operations Team.
• Manage registration data to ensure global compliance for product release.
• Archival of regulatory records, including but not limited to 510Ks, LTFs, US FDA RAIs, etc.

Required Skills and Experience

• Excellent written and verbal communication skills
• Excellent organizational, problem-solving, and statistical skills; able to manage priorities and workflow
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
• Ability to exercise self-supporting judgment
• Proficient on basic computer programs: Microsoft Excel, Word, PowerPoint
• Proven leadership and business acumen skills
• Proven ability to handle multiple projects and meet deadlines
• Excellent relational skills

University Hiring Program Eligibility Requirements:

• University Enrollment: Must be currently enrolled in and returning to an accredited degree-seeking academic program in the Fall.
• Internship Work Period: Must be available to work full-time (approximately 40 hours per week) during a 10-12 week period starting May or June. Specific start dates are shared during the recruiting process.

Required Education and Training

Currently working on completion of a bachelor’s or master’s degree in related field or equivalent; we will only consider students who are currently enrolled or plan be enrolled in a degree-seeking program.

Preferred Skills and Experience

• Regulatory Experience in a medical device company
• Proficiency with MS Office Suite
• Quick learner and detail-oriented
• Ability to work both autonomously and as part of a team
• Ability to work efficiently and effectively in a fast-paced environment

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 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.

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.

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.

EEO and AA Policy

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 (paid at an hourly rate), benefits, and a housing allowance. 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 relevant skills and experience for this internship, degree-seeking academic program (PhD, Master’s, Bachelor’s, etc), year in school, and location. The hourly rate is prorated against the intern program salaries listed and total program compensation will be based on internship duration.