Regulatory Affairs Manager-US

2 months 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

Senior Risk & Audit Specialist

RemoteWoman 1-10 Internet Software & Services

Upsun is hiring a Senior Risk & Audit Specialist to help keep its global security, risk, audit, and compliance program on track across a remote, cross-functional organization.

HIPAA
11 hours, 27 minutes ago

Privacy and Compliance Analyst (Remote)

BIS Safety Software Internet Software & Services

BIS Safety Software is hiring a remote Privacy and Compliance Analyst to support its risk, privacy, and compliance operations for a SaaS platform serving organizations that manage safety, learning, and compliance.

Cybersecurity
11 hours, 42 minutes ago

PCI Compliance Consultant

Avertium 251-1K IT Services

Avertium is seeking a Remote PCI Compliance Consultant to lead PCI audit engagements and advise clients in the Risk & Compliance practice on secure, compliant solutions.

Cybersecurity Network Security
11 hours, 42 minutes ago

Senior Compliance Consultant

Planet Technologies 251-1K Internet Software & Services

Planet Technologies is hiring a Senior Compliance Consultant to support remote security and compliance projects for public sector, defense industrial base, and commercial customers, with a focus on developing and delivering compliance solutions and strategies.

Azure HIPAA
11 hours, 43 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