Regulatory Affairs Specialiist

Main Responsibilities:

• Provides strategic planning and leadership of the Regulatory Affairs team – 8 employees (direct and matrix reporting).
• Ensures development and timely execution of the regulatory strategies for innovative products to support the fastest entrance to the markets across RU&CIS Cluster.
• Ensures development and timely execution of the regulatory strategies for legacy portfolio across RU&CIS Cluster.
• Provides strategic input into regulatory development programs, lifecycle management, and compliance activities.
• Supports cross-functional teams and projects with regulatory insights.
• Supports shaping of regulatory environment, advocacy and intelligence activities.
• Be the face of the organization to regulators, participates in appropriate forums and conveys the Company’s point of view on all relevant matters; represents the company in industrial associations if needed.

​​​Requirements:

• Graduate in pharmacy/ biology/ chemistry/ engineering or medicine is preferable
• 3 years+ experience in Regulatory Affairs for medical devices
• Deep and strong expertise in regulation of medical devices registration for RU&CIS countries (incl. EAEU) and international regulation (e.g. FDA, MDR etc.)
• Team management experience 1+ years (in direct subordination and/ or project team management, including remote teams and management of 3rd parties
• Project management skills
• English (verbal and written) – Upper-Intermediate+
• Expertise in general business processes execution
• Goal oriented, responsible, dedicated
• Excellent communication and negotiation skills, good in listening, good problem-solving and influential skills

Conditions:

• Competitive salary & annual bonus
• Medical and life insurance
• Meal allowance
• Fitness compensation
• Mobile allowance
• Opportunities for professional development and growth