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
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