Regulatory Affairs Specialist

Job Summary

A company is looking for a Regulatory Affairs Specialist.

Key Responsibilities

• Draft, assemble, and file documentation and submission materials for regulatory authorities
• Ensure submissions are accurate, high quality, and compliant with regulations
• Assist in authoring CE Technical Files under EU MDR

Required Qualifications

• No more than 3 years of experience in US and EU MDR medical devices and MDSAP
• Experience in quality assurance or a degree in a scientific field
• AQS Certified with demonstrated certification for auditing
• Familiarity with QSR (21CFR820) and ISO13485 or similar regulated industries
• Experience in internal audits and supplier audits