
Global Regulatory Strategist for IVDs (FDA & ISO)
2SAN Inc., Norwood, MA, United States
A global diagnostics company seeks a Global Regulatory Specialist in Norwood, Massachusetts. The role involves ensuring compliance for Class 2 and 3 Self-Test In Vitro Diagnostic devices. Responsibilities include monitoring regulatory listings, preparing submissions, and collaborating with product development teams. The ideal candidate has over 3 years in regulatory affairs, with a focus on IVDs, and strong analytical and communication skills. A bachelor's degree in a relevant scientific discipline is required. Competitive compensation and a dynamic work environment are offered.
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