Senior Regulatory Affairs Specialist - OUS Support

Intuitive Surgical, Inc.; Sunnyvale (CA); Vor Ort; USD 152.000 - 218.000; Vollzeit

Zusammenfassung

Intuitive Surgical, Inc. in Sunnyvale, CA, seeks an experienced Regulatory Affairs professional to lead regulatory project management, strategic submissions, and global compliance across non-US markets for complex medical devices.

In this role you will coordinate global regulatory teams, advise on regulatory strategies, and review critical documentation, leveraging 8+ years of experience and a relevant bachelor’s degree.

Qualifikationen

• 8+ years of experience in regulatory affairs or equivalent.
• Experience with complex product submissions for Asia Pacific, Latin America and other OUS markets.
• Regulatory strategy and cross-functional guidance experience.

Aufgaben

• Coordinate and manage OUS global regulatory teams for product registrations and variations.
• Assist with regulatory strategies for OUS markets.
• Advise cross-functional teams on global compliance requirements.
• Provide expert guidance in interpretation of international regulations.
• Represent regulatory affairs team in project meetings.
• Review, approve, and update project documentation.

Kenntnisse

Regulatory affairs

Global regulatory requirements

Project leadership

Communication skills

Ausbildung

Bachelor's degree in a relevant discipline

Jobbeschreibung

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies-like the da Vinci surgical system and Ion-have transformed how care is delivered for millions of patients worldwide.

We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful-because every improvement we make has the potential to change a life.

If you're ready to contribute to something bigger than yourself and help transform the future of healthcare, you'll find your purpose here.

Job Description

Primary Function of Position

This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in OUS regulated markets for complex products.

Essential Job Duties

• Coordinate and manage OUS global regulatory teams for product registrations and variations.
• Assist with regulatory strategies for OUS markets.
• Advise cross-functional teams on global compliance requirements.
• Provide expert guidance in interpretation of international regulations.
• Represent regulatory affairs team in project meetings.
• Review, approve, and update project documentation.

Required Experience and Education

• 8+ years of experience in regulatory affairs and bachelor's degree in a relevant discipline, or equivalent combination of education and experience.
• Experience with complex product submissions for Asia Pacific, Latin America and other OUS markets

Required Knowledge, Skills and Abilities

• OUS Agency negotiation and strategic planning proficiency.
• Expertise in global regulatory requirements and registration processes.
• Advanced project leadership and communication skills.
• Technical documentation review and approval capabilities.

Physical Requirements

• Not applicable

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

• U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
• Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).
• For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.
• 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.
• This position may be filled at a different job level than listed here depending on business need and/or on the selected candidate's experience, knowledge and skills.
• Compensation will be based primarily on the job level at which the role is filled and the candidate's qualifications, consistent with applicable law.

Accommodation & Accessibility Notice:

Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at (email protected) .

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 compensation ranges are listed.

• Base Compensation Range Region 1: $151,700 USD - $218,300 USD
• Base Compensation Range Region 2: $128,900 USD - $185,600 USD
• Shift: Day
• Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.