Regulatory Afairs Manager (medical devices)
- Требуемый опыт работы
- От 1 до 3 лет
Our client is an international company, one of the leaders in the field of health and hygiene, offers innovative developments in these areas and cares for patients around the world.
- Participation in global projects to localization the production of medical devices
- Competitive salary and monthly bonus level
- Medical insurance
- Life insurance, meal allowance, mobile compensation;
- Internal and external educational courses and trainings;
- Leading regulatory programs for Company in Russia & CIS to ensure compliance over products lifecycle;
- Support EU trade compliance and provide registration expertise to enable business growth, compliance, customer value and competitive position;
- Lead registration efforts to obtain and maintain product (medical devices) approvals in line with business targets;
- Preparing / reviewing applications, specifications, technical files, and other necessary documents in line with local regulations.
- Build/maintain relationships with relevant government agencies and customs.
- Monitoring the local legislations and registration documentation. Implement necessary changes if needed.
- University degree in pharmacology, chemistry, toxicology, engineering;
- 2-3 years experiance in Regulatory Affairs scope (medical devices);
- Business acumen and good communication skills;
- English (upper-intermediate).