🕒 8 days ago
Build and lead the compliance and anti-money-laundering function for a digital investment platform, owning regulatory controls, monitoring, reporting, and the relationship with Lithuanian regulators.
Regulatory Affairs Manager-US
📅 Mar 12
Regulatory AffairsFDA 510(k) SubmissionsSoftware As A Medical Device (samd)FDA Regulations
📜 Description
- Lead preparation and submission of FDA 510(k) filings for healthcare software and digital health products.
- Develop and execute regulatory strategies for product development and commercialization.
- Collaborate with product development, quality, clinical, and engineering teams to support regulatory compliance.
- Interpret FDA guidance for medical device software and digital health technologies.
- Partner with global regulatory teams on 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
Full 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
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