Similar Jobs
See allFunctional Analyst
Talan
Spain
Python
SQL
Senior Product Manager
ClickHouse
Global
Product Management
LLMs
SQL
Policy Analyst & Communications Coordinator
Western Landowners Alliance
US
Written Communication
Editing
Fact-checking
Customer Service & Dispatcher
Undisclosed Company
Philippines
Communication
Data Entry
Customer Service
Associate Project Manager, Supply Chain
Ampacity, LLC
US
Project Management
Supply Chain
Communication
About the Role:
- Lead key regulatory initiatives across QMS, product development, and international registrations.
- Drive regulatory documentation cleanup and maintain global submissions database.
- Develop and execute regulatory strategies for EU, UK, Canada, APAC, and LATAM.
Qualifications:
- Bachelor’s or Master’s degree in Engineering, Life Sciences, or related field.
- 5-8+ years of progressive regulatory experience in medical devices or digital health.
- Strong knowledge of FDA QMSR, EU MDR, ISO 13485, and global submissions.
Work Environment:
- Fully remote position within the United States, with expected travel.
- Fast-paced, innovation-driven environment with cross-functional collaboration.
- Opportunity to contribute to AI-powered software and connected hardware for healthcare.
Jobgether
This is a high-impact regulatory role supporting the development and global expansion of innovative medical devices and digital health technologies. The company works with multidisciplinary teams spanning engineering, medicine, research, and technology, contributing to technologies designed to improve patient care at scale.