Regulatory Affairs Specialist

One of the largest distributor of healthcare products is looking for "REGULATORY AFFAIRS SPECIALIST".

Responsibilities:

- Obtaining CE marking of Medical Devices forthe European market
- Creation of technical files for new Medical Devices (check list, list of applicable International Standards or guidance documents, risk analysis)
- Preparation of Clinical Evaluation Reports for submission to regulatory agencies
- Communication with the suppliers to obtain the specifications, test reports to populate the Technical files
- Maintenance of supplier ISO Certification (audit reports, test reports, PMS)
- Annual review of existing Medical Devices Technical files
- Review of product and manufacturing changes for compliance with applicable regulations (Change Control)
- Review of protocols and reports to support regulatory submissions
- Preparation of appropriate documentation for annual renewals
- Communication and coordination of regulatory activities with other departments
- Demonstration of strong working knowledge of global regulations, guidelines and standards related to commercialization and post market surveillance
- Demonstration of strong working knowledge of clinical and technical concepts and applications related to commercialized products
- Maintenance of current knowledge base on existing and emerging regulations, standards and guidance documents and applythem to change control sign offs.
- Application of internal policies and procedures, e.g., QualityAssurance, CAPA, SOPs, to everyday activities

- Technical education (Quality, Regulatrory)
- Active knowledge of English
- Strong written and oral communication - Negotiations skills
- Technical and product knowledge

- Stable international company
- Salary
- Social benefits

Are you interested in this position? Please fill in the contact form or send us your CV both in English and Slovak language with the ref. number in the subject of your application.

If you have had an interview in Grafton already, please contact your consultant directly via e-mail.



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