Senior Regulatory Affairs Specialist

A company is looking for a Senior Regulatory Affairs Specialist - IVD. Key Responsibilities Lead product lifecycle management project teams and support reporting assessments for product and facility changes Oversee QMS/Compliance activities, including audits, Post Market Surveillance, and CAPA Collaborate with cross-functional teams to assess regulatory impacts and ensure proper documentation for market protection Required Qualifications Bachelor's degree with 5+ years of related experience or Master's degree with 3+ years of related experience Understanding of Regulatory Affairs concepts and regulations for IVD diagnostic products Knowledge of US-IVD, CE-IVDD, and CE-IVDR governance Familiarity with QMS and ISO standards, including ISO 13485

May 19, 2025 - 16:50

A company is looking for a Senior Regulatory Affairs Specialist - IVD. Key Responsibilities Lead product lifecycle management project teams and support reporting assessments for product and facility changes Oversee QMS/Compliance activities, including audits, Post Market Surveillance, and CAPA Collaborate with cross-functional teams to assess regulatory impacts and ensure proper documentation for market protection Required Qualifications Bachelor's degree with 5+ years of related experience or Master's degree with 3+ years of related experience Understanding of Regulatory Affairs concepts and regulations for IVD diagnostic products Knowledge of US-IVD, CE-IVDD, and CE-IVDR governance Familiarity with QMS and ISO standards, including ISO 13485