Regulatory Affairs Manager-US

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

Symmetrio is recruiting for our clientfor a Regulatory Affairs Manager to lead U.S. regulatory strategy and submissions for innovative healthcare software products. This role will focus onFDA 510(k) submissionsand regulatory pathways forSoftware as a Medical Device (SaMD)within a global, multinational environment.

Responsibilities

• Lead preparation and submission ofFDA 510(k) filingsfor 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 tomedical device software and digital health technologies
• Partner with global regulatory teams to support international regulatory initiatives

Qualifications

• 5–10+ years of regulatory affairs experience inmedical devices or healthcare software
• Proven experience withFDA 510(k) submissions, ideally for software-based medical devices
• Strong knowledge ofSaMD, FDA regulations, and quality standards (21 CFR Part 820, ISO 13485, IEC 62304)
• Experience working within amultinational organization
• Strong cross-functional collaboration and communication skills