Regulatory Affairs Specialist
hace 4 semanas
Our client is a pioneering force in the medical and aesthetic device industry, renowned for its innovative products and commitment to excellence. With a global presence and a team of dedicated professionals, we strive to push the boundaries of what is possible in healthcare.
Job OverviewAs a Regulatory Affairs Specialist, you will play a vital role in ensuring the compliance of our medical devices with regulatory requirements across various markets. This position requires close collaboration with regulatory bodies, internal departments, and customers to manage product registrations, maintain technical documentation, and support compliance processes. Your work will directly contribute to the global market access of innovative medical and aesthetic devices, ensuring product safety and regulatory integrity.
Key Responsibilities- Ensure regulatory compliance of medical devices across different countries
- Coordinate and prepare product registrations and notifications within deadlines
- Communicate with regulatory authorities for product registrations and updates
- Prepare and maintain technical files and other regulatory documents
- Legalize documents and certificates through notary offices and embassies for product approvals
- Provide support to customers with product data and regulatory information
- Ensure compliance for product exports, including managing Certificates of Origin
- Collaborate with marketing, purchasing, and engineering teams to meet regulatory requirements
- Handle the issuance of Free Sale Certificates and other required regulatory documents
- Support the registration of Economic Operators in the EUDAMED database
- Translate regulatory documents between Slovak and English when necessary
- Ensure compliance with organizational quality, environment, and health and safety standards
- Academic degree in life sciences, chemistry, or technical/engineering education
- 2+ years of experience in a similar regulatory affairs position
- Knowledge of regulatory issues and experience interfacing with local and international regulatory bodies
- Advanced computer skills (MS Office)
- Experience in medical writing is an advantage
- English: Advanced (C1)
- Slovak: Proficiency (C2)
- Competitive salary
- 13th salary in Q1 based on both company profits and individual employee performance
- Reimbursement for commuting expenses
- Great office environment and team culture
- Long-term contract with the potential for growth
We are committed to creating innovative products that make a difference in people's lives. Join us and be part of a dynamic team that is shaping the future of healthcare.
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