What are the responsibilities and job description for the Regulatory Research Associate position at Coforge?
Job Title: Regulatory Research Associate
Skills: Research and monitor FDA, EU MDR, and other global regulatory, regulatory intelligence reports
Experience: 2-3 Years
Location: Menlo Park, CA
We at Coforge are hiring Regulatory Research Associate with the following skillset:
- 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.
- 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.
- 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.
- 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.