[Skip to main content](#main-content) [OpenNash Jobs](https://jobs.opennash.com/) [Hiring report](/reports/hiring/) · [All Intuitive jobs](https://jobs.opennash.com/companies/intuitive/) · [Search jobs](/search/) 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 August 6, 2026. Check that it is still open and apply there. [Apply on Intuitive’s careers site →](https://jobs.smartrecruiters.com/Intuitive/744000141964309-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 The Sr. Regulatory Affairs Specialist’s primary responsibilities include developing regulatory plans, reviewing design input/output documentation, identification of applicable standards and guidance documents, performing regulatory assessments to determine the impact of design/process changes, preparing regulatory submissions, maintaining regulatory filings and licenses. ### Essential Job Duties - Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation. - Determine regulatory pathways and formulate regulatory strategies for the U.S. and Canadian markets. Assess regulatory impact on design, materials, labeling, packaging, manufacturing processes, and facility changes. Influence and lead global regulatory strategies. - Author and lead regulatory documentation and submissions, including U.S. FDA 510(k) premarket notifications, internal Letters to File,, pre-submissions, Health Canada submissions with minimal supervision. - Coordinate with technical experts to provide additional data/information requested by regulatory agencies and prepare responses to facilitate regulatory approvals. - Provide risk-based guidance and regulatory input to projects and issues, ensuring cross- functional alignment and resolution. - Collaborate with international counterparts to support global regulatory submissions, approvals, and implementation rollouts. ## Qualifications ### Required Skills and Experience - Minimum 8 years of regulatory affairs experience working in a medical device company (can be in combination with a regulatory affairs master degree; e.g., Masters in Regulatory Science) - In-depth understanding of US Medical Device regulations, Health Canada guidance and EU MDR. - Regulatory working knowledge of product lifecycle management, design controls, risk management, verification and validation, and product labeling requirement - Ability to work in a fast-paced environment and handle multiple projects simultaneously - Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions - Team player who seeks to help and learn from colleagues seeing the department success as their own - Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism - Proactively seeks to develop and become well-versed within the regulatory landscape. 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. ### Preferred Skills and Experience - RAPS Regulatory Affairs Certification (RAC) is a plus. ## At a glance - Posted by the employer: Aug 6, 2026 - First seen by OpenNash: Oct 13, 2026 - Last checked: Oct 20, 2026 - Listed for: 75 days - Location: Sunnyvale, CA, United States - Employment type: Full-time[Apply on Intuitive’s careers site →](https://jobs.smartrecruiters.com/Intuitive/744000141964309-senior-regulatory-affairs-specialist) ## More jobs at Intuitive ### [Assistant General Counsel](https://jobs.opennash.com/companies/intuitive/jobs/84b7b46444b3136c5c11/) Sunnyvale, CA, United States ### [Assistant General Counsel, International Trade](https://jobs.opennash.com/companies/intuitive/jobs/4de2ce3d04c29a00b015/) Sunnyvale, CA, United States ### [Environmental Compliance Program Manager](https://jobs.opennash.com/companies/intuitive/jobs/5d123085375ed0a7bcd1/) Sunnyvale, CA, United States ### [Hardware Compliance Engineer](https://jobs.opennash.com/companies/intuitive/jobs/b4c0263335e96a497174/) Sunnyvale, CA, United States ### [Principal Regulatory Affairs](https://jobs.opennash.com/companies/intuitive/jobs/3e6cd07092c59e6073ee/) Sunnyvale, CA, United States ## Similar jobs at other companies ### [Principal Regulatory Affairs Specialist](https://jobs.opennash.com/companies/cardinal-health/jobs/33905438205fffb92ba7/) Cardinal Health · International ### [Global Regulatory Affairs Manager, Oncology](https://jobs.opennash.com/companies/gsk/jobs/09fdd8d7e12226e3ad65/) GSK · Rockville, Maryland, United States of America ### [Director, Global Regulatory Affairs (GRL)](https://jobs.opennash.com/companies/daiichi-sankyo/jobs/23bdbd6a298974011fee/) Daiichi Sankyo · Basking Ridge, NJ, USA ### [Director, Regulatory Affairs, Companion Diagnostics](https://jobs.opennash.com/companies/daiichi-sankyo/jobs/fdf9cbaa775b4385105d/) Daiichi Sankyo · Basking Ridge, NJ, USA ### [Head of US Regulatory Affairs Advertising and Promotion, Global Regulatory Affairs](https://jobs.opennash.com/companies/viatris/jobs/736e7dfaffb1fb1dc513/) Viatris · Washington, District of Columbia, USA [Jobs in Sunnyvale, CA](/locations/us/ca/sunnyvale/)[Jobs in California](/locations/us-ca/)[Legal & Compliance jobs](/functions/legal-compliance/) OpenNash lists jobs from employers’ own careers sites and does not handle applications. Dates come from the employer where stated; “first seen” and “last checked” are our own observations. OpenNash Jobs · Official listings with dates and links to the employer. [Weekly hiring report](/reports/hiring/) · [Methodology](/methodology/)