Senior Regulatory Affairs Specialist

Job Summary

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