Regulatory Affairs Manager-US

2 months, 3 weeks 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

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