Overview In this role you drive regulatory strategy for Surgical Robotics products, leading submissions and regulatory communications in the US and Canada. You will guide cross-functional teams on design, development, and marketing from a regulatory perspective, shaping how products meet standards and timelines. You manage compliance programs and contribute to continuous improvement of RA/QA processes. This position offers impact in a mission-driven company focused on advancing diagnostic technologies. You will work in a collaborative environment with opportunities to influence regulatory strategy for innovative surgical robotics solutions.
Compensation / Benefits- healthcare plan (medical, vision, dental)
- annual incentive bonus
- paid time off
- parental leave
- bereavement leave
- 401(K)
Responsibilities- Lead preparation and submission of FDA and Health Canada applications; respond to agency queries with data-driven summaries
- Maintain device establishments registrations, listings, and licensing renewals across regions
- Review regulatory materials for accuracy and ensure alignment with strategy
- Provide regulatory guidance to cross-functional teams on design, development, and marketing
- Manage RA procedures to sustain or enhance compliance and drive internal process improvements
- Stay current with applicable regulations and guidelines for medical devices
- Develop regulatory strategies for planned changes and guidance on requirements
- Support internal and external audits (ISO and regulatory bodies)
- Contribute to quality management system improvements and post-market activities
Key requirements- Bachelor's degree in science-related field; 7+ years in medical device Regulatory Affairs
- Experience with FDA and Health Canada regulatory requirements (21 CFR 820, ISO 13485, ISO 14971, CMDR) and 510(k) processes
- Knowledge of IEC/ISO standards (IEC 62304, IEC 60601, IEC 62366, ISO 14155) and usability, software, cybersecurity, labeling expectations
- Direct interaction with regulatory agencies; RAC and PMP are pluses; Surgical robotics experience preferred
- Strong communication, relationship-building, and cross-functional collaboration skills
- Proficiency in IT tools (Microsoft Office/Outlook, Adobe)
- excellent communication
- strong organizational skills
- attention to detail
- FDA/Health Canada regulatory knowledge (21 CFR 820, 510(k
- ISO 13485, ISO 14971, CMDR
- IEC 62304, IEC 60601, IEC 62366, ISO 14155
