Вакансия - Regulatory Affairs Manager (medical devices)

Regulatory Affairs Manager (medical devices)

Responsibilities

  • 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.
Requirements
  • 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).
Conditions;
  • Official employment;
  • Meal and Telephone compensations;
  • Voluntary health insurance;
  • Professional development opportunities

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