Regulatory Manager-US
Location
United States
Posted
3 days ago
Salary
Not specified
Job Description
Symmetrio is recruiting for our client for a Regulatory Affairs Manager to lead U.S. regulatory strategy and submissions for innovative healthcare software products. This role will focus on FDA 510(k) submissions and regulatory pathways for Software as a Medical Device (SaMD) within a global, multinational environment.
Key Responsibilities
- Lead preparation and submission of FDA 510(k) filings for healthcare software and digital health products
- Develop and execute regulatory strategies supporting product development and commercialization
- Collaborate with product development, quality, clinical, and engineering teams to ensure regulatory compliance
- Interpret FDA guidance related to medical device software and digital health technologies
- Partner with global regulatory teams to support international regulatory initiatives
Job Requirements
- 5–10+ years of regulatory affairs experience in medical devices or healthcare software
- Proven experience with FDA 510(k) submissions, ideally for software-based medical devices
- Strong knowledge of SaMD, FDA regulations, and quality standards (21 CFR Part 820, ISO 13485, IEC 62304)
- Experience working within a multinational organization
- Strong cross-functional collaboration and communication skills
Related Guides
Related Categories
Related Job Pages
More Manager Jobs
Senior Delivery Manager
Friends From The CityFriends From The City is a full-service digital company that delivers best-in-class HCD experiences to federal agencies.
Delivery Manager overseeing platform development for government services
Trust & Safety Manager
Pareto.AIPareto is a talent-first platform harnessing the top 0.01% of data labelers to deliver premium AI/LLM training data.
Trust & Safety Manager overseeing integrity functions for Pareto.AI
We’re looking for a Senior Manager of Professional Services to lead delivery for a portion of the Enterprise segment within the Professional Services organization. In this role, you’ll be responsible for driving high-quality implementations, consulting engagements, and adviso...
Senior Wind Hub Manager
Switzerland Global EnterpriseWe support Swiss SMEs in their international business and help innovative foreign companies to establish in Switzerland.
Sr. Wind Hub Manager in charge of hub operations and customer relationships at GE Vernova
