Regulatory Affairs Specialist The Regulatory Affairs Specialist assists the Senior Regulatory Affairs Manager in the registration of medical devices in EXTRA-CEE countries following a plan that is constantly updated in accordance with company strategy. Essential Duties and Responsibilities Prepares, updates, and reviews the documents for use in regulatory dossiers in accordance with EU MOR 745/2017 and international requirements. Prepares and manages technical documentation needed for submission and registrations. Interacts with project development teams to collect the information needed for submissions/registrations and advises them on matters related to regulatory processes and compliance. Registers, monitors, and maintains registrations for the company's medical devices with EXTRA-CEE countries' competent authorities as appropriate. Assists in compliance with the Medical Device Regulations (MDR) in the EU, Canadian Medical Device Directive, FDA, TGA, ANVISA, Japan Authority, and other regulatory agencies. Proficient in applicable standards and regulations including: ISO 13485, ISO 9001, ISO 14971, ISO 10993, ISO 11607, and MEDDEV guidelines. Prepares and updates the Quality and Regulatory Agreements necessary for registration purposes, distribution contracts, and technical assistance for the EXTRA-CEE countries concerned. Follows and promotes corporate quality procedures and standards to achieve and maintain adequate results. Actively participates in audit activities. Work Experience - Required Qualifications • At least 3 years' experience with Regulatory Affairs in the medical device industry preferred. • Fluent in English. Educational Requirements Bachelor's Degree in a scientific discipline. Seniority Level Associate Employment Type Full-time Job Function Other, Quality Assurance, and Writing/Editing Industries Manufacturing, Machinery Manufacturing, and Medical Equipment Manufacturing J-18808-Ljbffr