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Intuitive · Sunnyvale, CA

# Senior Regulatory Affairs Specialist - NPD Clinical Studies

Sunnyvale, CA, United States Full-time Senior individual contributor Healthcare & Clinical 

Listed on Intuitive’s official careers site. Posted November 2, 2026. Check that it is still open and apply there.
[Apply on Intuitive’s careers site →](https://jobs.smartrecruiters.com/Intuitive/744000159224230-senior-regulatory-affairs-specialist-npd-clinical-studies)

[OpenNash Jobs](https://jobs.opennash.com/) / [Intuitive](https://jobs.opennash.com/companies/intuitive/) / Senior Regulatory Affairs Specialist - NPD Clinical Studies

## Job description

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

### Essential Job Duties
- Develop regulatory strategies for new product development and market entry.
- Advise cross-functional teams on global compliance requirements.
- Lead regulatory submissions, agency communications and strategy for the US and Canada for complex product approvals.
- Provide expert guidance in interpretation of international regulations.
- Represent regulatory affairs team in project meetings.
- Coordinate with OUS global regulatory teams for product registrations and variations.
- Review, approve, and update project documentation.

## Qualifications

### Required Experience and Education
- 6–8 years of experience in regulatory affairs and bachelor’s degree in a relevant discipline, or equivalent combination of education and experience. Required Knowledge, Skills and Abilities
- 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.
- Experience with audits, submissions, and training.

## At a glance
- Posted by the employer: Nov 2, 2026
- First seen by OpenNash: Nov 3, 2026
- Last checked: Nov 10, 2026
- Listed for: 8 days
- Location: Sunnyvale, CA, United States
- Employment type: Full-time[Apply on Intuitive’s careers site →](https://jobs.smartrecruiters.com/Intuitive/744000159224230-senior-regulatory-affairs-specialist-npd-clinical-studies)

## Hiring at Intuitive
- Open jobs: 812
- New in the last 7 days: After two weekly collections
- Tracked since: Oct 13, 2026

[All Intuitive jobs](https://jobs.opennash.com/companies/intuitive/) · [Weekly hiring report](/reports/hiring/)

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### [Sr. Clinical Research Associate](https://jobs.opennash.com/companies/intuitive/jobs/ec6eea70ea2dfea42516/)

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### [Sr. Clinical Research Engineer](https://jobs.opennash.com/companies/intuitive/jobs/7f0e96233a377c18a90d/)

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