Regulatory Manager-US

Location

United States

Posted

106 days ago

Salary

0

Seniority

Lead

English

Job Description

Regulatory Manager-US

Symmetrio

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

Job 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

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