Regulatory Affairs Manager-US

2 hours, 19 minutes ago
Symmetrio

Symmetrio

Symmetrio is a top Staffing and Recruiting company in the Philadelphia region, specializing in recruiting qualified full-time candidates, providing staff augmentation services, and offering advisory services to help clients meet their corporate objecti...

Professional Services

Description

  • Lead preparation and submission of FDA 510(k) filings for healthcare software and digital health products.
  • Develop and execute regulatory strategies that support 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 including 21 CFR Part 820, ISO 13485, and IEC 62304.
  • Experience working within a multinational organization.
  • Strong cross-functional collaboration and communication skills.

Interested in this position?

Apply directly on the company website

Apply Now

Similar Roles

Director, Trade Compliance (International)

SCOPE Recruiting 11-50 Professional Services

Director of Trade Compliance for a Fremont, CA-based supply chain and procurement organization, responsible for leading import-centric compliance operations across the U.S., Canada, Australia, and broader APAC/Oceania to enable compliant, cost-effective market access for utility-scale solar growth.

ERP Oracle
1 hour, 4 minutes ago

FOIA Analyst

Contact Government Services 1-10 Professional Services

CGS is hiring a FOIA Analyst to support a large federal agency’s legal mission by processing Freedom of Information Act requests and managing related correspondence and records review.

1 hour, 49 minutes ago

FOIA Analyst

Contact Government Services 1-10 Professional Services

CGS is hiring a FOIA Analyst to support a large federal agency’s legal mission by processing requests, preparing correspondence, and managing records review and release decisions.

1 hour, 49 minutes ago

Senior Engineering Manager - Compliance

Malt 1K-5K IT Services

Malt is hiring a Senior Engineering Manager to lead the Compliance product engineering squads in Paris, owning delivery, technical strategy, and team leadership for the systems that keep freelancer and client interactions secure and trustworthy.

Java Kotlin Microservices
1 hour, 49 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers