Regulatory Affairs Specialist

For our client, intgernational health care company, we are looking for a suitable candidate for the role of:

"Regulatory Affairs Specialist"

We are looking for a flexible and customer oriented Regulatory Affairs Specialist who will be in charge of the Regulatory Affairs / Quality Assurance (RA / QA) activities for medical devices commercialized by our client in ČR. The RA Specialist will be also supporting the Marketing/Sales depart. with providing the relevant information and documentation.

Responsibilities of the RA Specialist:
- Managing notification process in ČR according to the latest legislation
- Monitoring Medical Devices Vigilance procedures according to EU / National Laws and Rules
- Archiving and follow-up of quality complaints, incidents or adverse events from customers and reporting to the concerned departments and to the health authorities
- Supporting Marketing/Sales Depart. for promotional and advertising material regarding commercialized medical devices;
- Provide assistance to other departments as requested, cooperation with colleagues throughout the CEE Regulatory Affairs and Quality Assurance organization


Candidate´s profile:
- 1-3 years experience from a similar position
- Fluency in czech and in english
- Knowledge of the medical devices legislation in ČR, EU legislation would be advantage
- Problem solving skills, good communication skills and customer service attitude

Our client offers:
- Stable background of well established, international company
- Independent position with possibility for growth
- Cooperation with other branches in EMEA region countries
- great salary and benefit package
- immediate start is possible

Nemocnice, ambulantní lékařská činnost, další zdravotní péče

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