Regulatory Research Associate

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.