Regulatory Affairs Specialist

EU MDR Compliance: Contribute to preparation and implementation of MDR requirements for medical devices, ensuring full compliance with European regulations and industry standards.
Global Regulatory Compliance: Coordinate the regulatory strategy for markets beyond the EU, including the US (FDA) and other relevant international territories.
Regulatory Documentation: Prepare, review, and maintain regulatory documentation for multiple regions, including technical files, clinical evaluation reports (CERs), risk management files, and declarations of conformity in line with MDR and other global requirements.
Liaison with Notified Bodies and Regulatory Agencies: Serve as one of the point of contact with Notified Bodies (for MDR) and regulatory authorities (e.g., FDA, Health Canada, TGA,) for all matters related to device certification, audits, and inspections.