SoluStaff
51 - 200 employees
🎯 Recruiter
👥 HR Tech
Recruitment • HR Tech • Consulting
Symmetrio is a full-service recruiting, staffing, and consulting company with decades of experience across various high-growth industries. They specialize in permanent placement, contract-to-hire, and staff augmentation, focusing on aligning talent with client goals and cultures. Symmetrio offers tailored recruitment solutions and advisory services in sectors such as life sciences, information technology, engineering, medical devices, logistics solutions, manufacturing, and building automation. Their team of talent acquisition experts is committed to understanding clients’ organizational needs and delivering specialized professionals to meet these challenges. With a strong emphasis on trust, understanding, and collaboration, Symmetrio aims to optimize operations and drive innovation and excellence for their clients.
Regulatory Manager
Job not on LinkedIn
🕒 March 12
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SoluStaff
51 - 200 employees
🎯 Recruiter
👥 HR Tech
Recruitment • HR Tech • Consulting
Symmetrio is a full-service recruiting, staffing, and consulting company with decades of experience across various high-growth industries. They specialize in permanent placement, contract-to-hire, and staff augmentation, focusing on aligning talent with client goals and cultures. Symmetrio offers tailored recruitment solutions and advisory services in sectors such as life sciences, information technology, engineering, medical devices, logistics solutions, manufacturing, and building automation. Their team of talent acquisition experts is committed to understanding clients’ organizational needs and delivering specialized professionals to meet these challenges. With a strong emphasis on trust, understanding, and collaboration, Symmetrio aims to optimize operations and drive innovation and excellence for their clients.
📋 Description
• 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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