Regulatory Affairs Specialist

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