Regulatory Affairs Manager (medical devices)
- Leading regulatory programs for Company in Russia & CIS to ensure compliance over product’s lifecycle (medical devices);
- 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.
Local IFU/labeling support
- Deliver regulatory support to internal and external interfaces in the country.
- University degree in pharmacology, chemistry, toxicology, engineering or related life science degree with over three years of professional experience;
- Highly valued proven professional experience on Trade Compliance.
- Familiarity with regulatory requirements and standards governing trade compliance, import, distribution and sales in Russia & CIS;
- Track record of exposure to relevant regulatory agencies and customs;
- Strong leadership and interpersonal skills;
- Business acumen and good communication skills;
- Structured working habit and practical thinking;
- Passion and proactive attitude;
- Required Language skills: English (upper-intermediate).
- Official employment;
- Meal and Telephone compensations;
- Voluntary health insurance;
- Professional development opportunities