Job Title: Regulatory Affairs Specialist (Remote) Summary: Seeking a fluent French speaker to guide EU MDR project teams. Responsible for preparing and submitting EU MDR documentation for medical devices (Class , IIa, IIb, I sterile or reusable) for CE marking and EU commercial release. Collaborate with cross-functional teams and Notified Bodies. Supervision: Reports to Sr. Manager or Director of Regulatory Affairs. No supervisory responsibilities. Essential Duties: Ensure EU MDR compliance for
Job Title: Senior Regulatory Affairs Specialist (Medical Devices) Location: Remote Duration: Long term contract Job Description: -Subject Matter Expert for Class II and Class 510(K) submission. -Hands on experience with 510(k) authoring, submissions, and communicating with the FDA. -Hands on experience with software as a Medical Device (SaMD) and validation requirements and applicable consensus standards. Key Responsibilities: -Authoring US FDA 510(k) submission using eSTAR submission tool.
