- Полный рабочий день
Regulatory Affairs Expert
17 января 2018, 16:20
- Ensure registration and certification of In vitro diagnostics and Metrology products in Russia.
- Develop and implement programs / processes for the registration of these products ensuring regulatory requirements are met.
- Provide Guidance and Clarification to the internal team for regulatory requirements. Ensure regulatory project deadlines and performance standards are established and met.
- Represent company to external bodies for standards and product regulations at the national/regional/global level.
- Assess requirements and identify strategies for earliest possible approvals of clinical trials applications.
- Degree in in Chemistry, Biology, Engineering or related field.
- 5+ years of experience in Russian and CIS medical device Regulatory Affairs (Preferably IVD). Additional experience in Metrology registration preferred.
- Understanding of international IVD regulations and Russian requirements.
- Strong written and verbal communication skills in English.
- Work experience in an international company.
- Competitive salary (is discussed).
- Life insurance, voluntary medical insurance and so on.
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