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Intuitive · Sunnyvale, CA

# Senior Regulatory Affairs Specialist

Sunnyvale, CA, United States Full-time Senior individual contributor Legal & Compliance 

Listed on Intuitive’s official careers site. Posted September 3, 2026. Check that it is still open and apply there.
[Apply on Intuitive’s careers site →](https://jobs.smartrecruiters.com/Intuitive/744000147349619-senior-regulatory-affairs-specialist)

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

## 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.

### Essential Job Duties
- Lead global regulatory submissions for product registrations and variations.
- Develop regulatory strategies for new product development and market entry.
- Advise cross-functional teams on global compliance requirements.
- Oversee preparation of technical files and documentation for audits.
- Manage agency communications for complex product approvals.
- Provide expert guidance in interpretation of international regulations.
- Review, approve, and update regulatory labeling and documentation.
- Mentor and coach regulatory affairs specialists.
- Track and report metrics on regulatory timelines and success rates.
- Represent regulatory affairs team in project meetings.

## Qualifications

Minimum 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
- Expertise in global regulatory requirements and registration processes.
- Advanced project leadership and communication skills.
- Technical documentation review and approval capabilities.
- Agency negotiation and strategic planning proficiency.
- Experience with audits, submissions, and training.

### Physical Requirements
- Not applicable

## At a glance
- Posted by the employer: Sep 3, 2026
- First seen by OpenNash: Oct 13, 2026
- Last checked: Oct 20, 2026
- Listed for: 47 days
- Location: Sunnyvale, CA, United States
- Employment type: Full-time[Apply on Intuitive’s careers site →](https://jobs.smartrecruiters.com/Intuitive/744000147349619-senior-regulatory-affairs-specialist)

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