Symmetrio

50 Symmetrio Jobs Hiring Near You

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 ...

Marketing Coordinator

San Diego, CA · On-site

$85K - $100K/yr

Symmetrio is recruiting for a Marketing Manager on behalf of an innovative startup medical device company experiencing exciting growth. This is an excellent opportunity for a hands-on, highly ...

Symmetrio is seeking multiple Field Service Engineers on behalf of a growing outpatient radiology organization. We're looking for a hands-on engineer experienced in MRI, CT, and digital X-ray systems.

Symmetrio is seeking multiple Field Service Engineers on behalf of a growing outpatient radiology organization. We're looking for a hands-on engineer experienced in MRI, CT, and digital X-ray systems.

Symmetrio is recruiting on behalf of a growing global medical technology company focused on advancing radiation therapy workflows. The client partners with hospitals, cancer centers, and healthcare ...

Symmetrio is seeking multiple Field Service Engineers on behalf of a growing outpatient radiology organization. We're looking for a hands-on engineer experienced in MRI, CT, and digital X-ray systems.

Symmetrio is recruiting a Strategic Account in the Western U.S. territory. Our client is a global medical technology company supporting hospitals and health systems with advanced solutions for ...

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Infographic showing various job openings at Symmetrio in the United States as of June 2026, with employment types broken down into 100% Full Time. Highlights an 20% Physical, and 80% Remote job distribution.

Regulatory Affairs Manager-US

Symmetrio

Remote

Full-time

Posted 7 days ago


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

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