# Regulatory Affairs Manager-US

**Company:** [Symmetrio](http://jobs.workable.com/companies/ioEiQLujpfBa32WwgQgrFq.md)
**Location:** Remote
**Workplace:** remote

[Apply for this job](http://jobs.workable.com/view/6bcec027-8359-4587-825b-cf514e6ca48c)

## 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

## 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