Senior Regulatory Affairs Specialist
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 full-time, employee position with a set schedule that will be onsite weekly, with the percentage of onsite work defined by the leader. The company is a global leader in robotic-assisted surgery and minimally invasive care, with technologies that have transformed how care is delivered for millions of patients worldwide. They are a team of engineers, clinicians, and innovators united by the purpose to make surgery smarter, safer, and more human. Their work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world. The problems they solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement they make has the potential to change a life. They are looking for individuals ready to contribute to something bigger than themselves and help transform the future of healthcare.
Requirements
- Minimum 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
