美国法规事务经理
Regulatory Affairs Manager-US
Symmetrio 正在为我们的客户招聘一名法规事务经理，负责创新医疗软件产品的美国法规策略和申报工作。该职位将专注于 FDA 510(k) 申报以及全球多国环境下的医疗器械软件（SaMD）法规路径。
主要职责
· 领导医疗软件和数字健康产品的 FDA 510(k) 申报准备工作
· 制定并执行支持产品开发和商业化的法规策略
· 与产品开发、质量、临床和工程团队合作，确保法规合规性
· 解读与医疗设备软件和数字健康技术相关的 FDA 指南
· 与全球法规团队合作，支持国际法规项目
要求
· 5–10+ 年医疗设备或医疗软件领域的法规事务经验
· 具有 FDA 510(k) 申报经验，最好是基于软件的医疗设备
· 精通 SaMD、FDA 法规及质量标准（21 CFR Part 820、ISO 13485、IEC 62304）
· 有在跨国组织工作的经验
· 具备出色的跨职能协作和沟通能力
最初发布于 Himalayas
查看英文原文
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
Originally posted on Himalayas