The Regulatory Affairs Specialist plays a crucial role in the registration of medical devices in EXTRA-CEE countries. As a key member of the regulatory team, you will assist the Senior Regulatory Affairs Manager in ensuring compliance with EU MDR 745/2017 and international requirements.
Main Responsibilities:
* Regulatory dossier preparation: Prepare, update and review documents for use in regulatory dossiers in accordance with EU MDR 745/2017 and international requirements.
* Technical document management: Prepare and manage technical documentation needed for submission and registrations.
* Project collaboration: Interact with project development teams to collect information needed for submissions/registrations and advise them on matters related to regulatory processes and compliance.
* Registration management: Register, monitor and maintain registrations for the company's medical devices with EXTRA-CEE countries' competent authorities as appropriate.
* Regulatory compliance: Assist in compliance to the Medical Device Regulations (MDR) in the EU, Canadian Medical Device Directive, FDA, TGA, ANVISA, Japan Authority and other regulatory agencies.
* Standards and regulations: Be proficient in applicable standards and regulations including: ISO 13485, ISO 9001, ISO 14971, ISO 10993, ISO 11607 and MEDDEV guidelines.
* Quality and regulatory agreements: Prepare and update quality and regulatory agreements necessary for registration purposes, distribution contracts and technical assistance for the EXTRA-CEE countries concerned.
* Audit participation: Actively participate in audit activities.
Requirements:
* At least 3 years' experience with Regulatory Affairs in the medical device industry.
* ISO 13485 certification.
* Fluent in English language.
* Internal Auditor qualifications preferred.
Educational Background:
Bachelor's Degree in scientific discipline; higher-level education degree preferred.