Regulatory Affairs Manager-US
About this role
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
- 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
Frequently Asked Questions
Is the salary disclosed for the Regulatory Affairs Manager-US position at Symmetrio?
The salary for this Regulatory Affairs Manager-US role at Symmetrio is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Is the Regulatory Affairs Manager-US job at Symmetrio remote?
Yes, this Regulatory Affairs Manager-US position at Symmetrio is remote, with team members based in TELECOMMUTE, United States. You can work from home or anywhere in the supported regions.
How do I apply for the Regulatory Affairs Manager-US position at Symmetrio?
Click the "Apply Now" button on this page. You will be redirected to Symmetrio's official application portal hosted on workable where you can submit your application directly.
When was the Regulatory Affairs Manager-US job at Symmetrio posted?
This Regulatory Affairs Manager-US position at Symmetrio was posted on Mar 12, 2026. Apply as soon as possible — early applications are often reviewed first.
Regulatory Affairs Manager-US
Symmetrio
You'll be redirected to Symmetrio's official application page on workable.