Symmetrio

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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 Manager

San Diego, CA · On-site

$85K - $100K/yr

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

Symmetrio is recruiting for a Marketing Coordinator 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 for our client, a multi-national medical device company, a Clinical Applications Specialist with a dosimetry background. This position requires a thorough knowledge of treatment ...

Marketing Manager

San Diego, CA · On-site

$85K - $100K/yr

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

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Infographic showing various job openings at Symmetrio in the United States as of July 2026, with employment types broken down into 100% Full Time. Highlights an 43% Physical, and 57% Remote job distribution.

Regulatory Affairs Manager-US

Symmetrio

Remote

Full-time

Posted 3 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