Senior Regulatory Affairs Specialist

Job Summary

A company is looking for a Remote Sr Regulatory Affairs Specialist.

Key Responsibilities

• Review design, labeling, supplier, and manufacturing changes for Class II medical devices
• Represent the Regulatory function in a cross-functional team setting
• Complete regulatory assessments for both USA and EU geographies

Required Qualifications

• University Degree with a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience
• 2-5 years of experience in reviewing changes and determining regulatory impact for Class II medical devices
• Strong understanding of change control for commercialized products
• Ability to work cross-functionally
• Advanced knowledge of regulatory procedures and changes