In this position, Regulatory Affairs Specialist will be responsible for regulatory compliance of medical devices distributed in CEE Central Region market with the main focus on Hungary. The role will assure timely notifications of medical devices and all tasks connected with. Provide support in RA matters to ensure compliance and business continuity. Main responsibilities: - Ensure regulatory clearance of medical devices being in product portfolio of client MDs within timelines. Coordination and preparation of product notifications and strategies. Managing product submissions and communication with national health authority. - Provide regulatory support to Tender Management, Health Economics & Reimbursement, Business, Distributors and Franchises. - Provide communication and updates to management regarding regulatory affairs and deliver RA trainings to local clusters. - Ensure timely communication and feedback on problems and events related to RA compliance - Collaboration in process of RA restrictions removal in distribution center. - Responsibility for approvals in systems linked to job duties and maintaining RA databases. - Establish and keep relationships with business partners and internal/external RA groups (MD) Franchise and DC - Monitor legislative situation, lead projects related to compliance and ensure that RA SOPs are updated and followed. - Support deployment of client Standards into LOC QMS related to RA aspects. - Collaborating with other departments to coordinate development of procedures, documents and controls to ensure compliance in a timely manner. Review and disposition document changes within areas of expertise per applicable procedures Contract for 1 year ( possibility of prolongation )
University education (Bachelor's degree)
University education (Master's degree)
Language and language level
Command of all the selected languages is required
English - Advanced (C1)
Hungarian - Advanced (C1)
Microsoft Excel - pokrocily
Microsoft Word - pokrocily
Number of years of experience
Personality requirements and skills
- Demonstrable knowledge of Regulatory, understanding of Medical Devices environment. - At least 1 year experience in Regulatory Affairs environment. - Excellent interpersonal skills - build and maintain relationships with internal and external partners. - Detailed planning and execution to achieve accurate and timely results. - Sense of importance and mission of the role.
Information about the selection process
The number of job openings
A brief description of your client
Your client's core business
Chemical industry, manufacture of pharmaceutical products
Contact person: Mária Ivanovičová
Email: [email protected]
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