Senior Regulatory Affairs Specialist
Intuitive•Sunnyvale, CA
•$128,900 - $218,300•Onsite
About The Position
This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in global regulated markets. It is a Senior Regulatory Affairs Specialist position within a company that is a global leader in robotic-assisted surgery and minimally invasive care. The company's technologies have transformed how care is delivered for millions of patients worldwide, with a purpose to make surgery smarter, safer, and more human. The work is challenging but meaningful, with the potential to change lives and transform the future of healthcare.
Requirements
- Minimum 8 years 6–8 years of experience in regulatory affairs and bachelor’s degree in a relevant discipline, or equivalent combination of education and experience.
- 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.
Responsibilities
- 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.
Benefits
- Market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
