Senior Regulatory Affairs Specialist (Medical Devices)

International pharmaceutical company is looking for Senior Regulatory Affairs Specialist (Medical Devices).

Your area of ​​responsibility will include:

• Manage the complete registration process for medical devices, including updates to existing dossiers (VIRD, VIRU);

• Coordinate document requests with manufacturers, utilizing their databases, SharePoint, or other sources;

• Prepare registration dossiers by developing local technical files, Instructions for Use (IFU), and other necessary documents for submission to regulatory authorities;

• Ensure timely registration of new products, maintain the registered product portfolio, monitor dossier validity, and update documentation as needed;

• Review product dossiers to verify accuracy and completeness;

• Collaborate with outsourcing partners and work cross-functionally within the organization;

• Participate in local Regulatory Affairs (RA) and Quality Assurance (QA) audits;

• Maintain and regularly update all relevant databases and tracking systems;

• Archive dossiers following company-established procedures;

• Review and approve promotional materials;

• Attend conferences and seminars hosted by state authorities related to the registration process.

Important for the company:

• Higher education; a background in Biomedical Engineering is preferred;

• Minimum 5 years of experience in Regulatory Affairs within the medical devices sector;

• English from level Upper-Intermediate;

• Results-driven, proactive, and self-initiated;

• Strong team player with excellent communication, collaboration, and analytical skills;

• Open-minded and adaptable.

The company offers the following benefits:

• Competitive salary with annual bonus;
• Medical and life insurance coverage;
• Meal allowance;
• Fitness reimbursement;
• Mobile phone allowance;
• Career development and growth opportunities.