Position: Regulatory Research Associate
Location: Menlo Park, CA 94025
Duration: Full Time
About the Role
We are seeking a proactive and intellectually curious Regulatory Research Associate to support regulatory strategy, compliance activities, and market intelligence for innovative wearable healthcare and wellness devices. This individual will help navigate a rapidly evolving regulatory landscape while supporting product development, submissions, and compliance initiatives across global markets.
The ideal candidate thrives in a fast-paced environment, embraces ambiguity, learns quickly, and enjoys solving complex problems while working across multiple teams.
Key Responsibilities:
· Research and monitor FDA, EU MDR, and other global regulatory requirements impacting wearable health and digital health technologies.
· Support the planning, preparation, and execution of regulatory submissions, registrations, and regulatory strategy documentation.
· Develop regulatory intelligence reports on emerging regulations, standards, competitors, and market trends.
· Coordinate responses to regulatory authority inquiries and support audit readiness activities.
· Review technical documentation, product materials, and labeling to ensure regulatory compliance.
· Maintain regulatory records, submission documentation, and compliance tracking systems.
· Partner with Product, Quality, Engineering, and Clinical teams throughout the product development lifecycle.
· Support the development of internal regulatory intelligence and knowledge management processes.
· Manage multiple projects simultaneously while tracking priorities, timelines, and deliverables.
Qualifications Required:
· Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, Public Health, or a related field.
· 2-3 years of experience in regulatory affairs, regulatory research, medical devices, digital health, or healthcare technology.
· Experience supporting FDA and/or global regulatory submissions and documentation.
· Strong analytical, research, writing, and communication skills.
· Demonstrated ability to manage multiple priorities in a fast-moving environment.
Preferred:
· Experience with wearable devices, connected health, digital health, or wellness technologies.
· Familiarity with FDA regulations, EU MDR, ISO standards, and global regulatory frameworks.
· Experience reviewing technical documentation and product claims.
Success Profile:
We're looking for someone who:
· Embraces ambiguity and isn't afraid of a little chaos.
· Learns quickly and adapts as priorities evolve.
· Has a strong "figure it out" mentality and takes ownership.
· Balances attention to detail with speed and execution.
· Works effectively across teams and functions.
· Is excited to help bring innovative healthcare technologies to market.
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