Regulatory Manager, SaMD & FDA 510(k) Strategy

Symmetrio; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

A healthcare consulting firm is looking for a Regulatory Affairs Manager to lead U.S. regulatory strategy and submissions for innovative healthcare software products. The ideal candidate will have 5–10+ years of regulatory experience, particularly with FDA 510(k) submissions for software-based medical devices. Strong knowledge of SaMD, along with collaboration skills across teams, is crucial for this role, which operates within a multinational environment.

Qualifications

• 5–10+ years of regulatory affairs experience in medical devices or healthcare software.
• Proven experience with FDA 510(k) submissions.
• Strong knowledge of SaMD, FDA regulations, and quality standards.

Responsibilities

• Lead preparation and submission of FDA 510(k) filings for healthcare software.
• Develop and execute regulatory strategies to support product development.
• Collaborate with cross-functional teams to ensure regulatory compliance.

Skills

Regulatory affairs experience

FDA regulations knowledge

Cross-functional collaboration

Tools

FDA 510(k)

ISO 13485

IEC 62304

Job description

A healthcare consulting firm is looking for a Regulatory Affairs Manager to lead U.S. regulatory strategy and submissions for innovative healthcare software products. The ideal candidate will have 5–10+ years of regulatory experience, particularly with FDA 510(k) submissions for software-based medical devices. Strong knowledge of SaMD, along with collaboration skills across teams, is crucial for this role, which operates within a multinational environment.