Regulatory Affairs Manager (Medical Devices)

Описание

International pharmaceutical company is looking for Regulatory Affairs Manager (Medical Devices) .

Your area of responsibility will include:

• Leading and strategically planning the Regulatory Affairs team (Surgery) consisting of 8 employees, managing both direct and matrix reporting lines;
• Developing and ensuring timely implementation of regulatory strategies for innovative products, aiming for the fastest market entry within the RU&CIS Cluster;
• Overseeing the creation and execution of regulatory strategies for the legacy product portfolio across the RU&CIS Cluster;
• Providing strategic guidance on regulatory development programs, product lifecycle management, and compliance activities;
• Support cross-functional teams and projects by offering regulatory expertise;
• Contribution to shaping the regulatory landscape, including advocacy and intelligence efforts;
• Acting as the company s representative to regulatory authorities, participation in relevant forums, communication the company s position on key matters, and representation the organization in industry associations when necessary.

Important for the company:

• Bachelor s degree preferably in pharmacy, biology, chemistry, engineering, or medicine;
• Minimum of 5 years experience in regulatory affairs focused on medical devices;
• Strong expertise in medical device registration regulations for RU&CIS countries (including EAEU) and international standards such as FDA and MDR;
• At least 1 year of experience managing teams of 5 or more employees, including direct supervision or project management, remote teams, and third-party coordination;
• English from level Upper-Intermediate.

The company offers the following benefits:

• Competitive salary;
• VHI from day one for the employee, children under 18, and a 50% discount for spouses;
• Annual bonus;
• Mobile phone, meal and fitness allowance;
• Opportunities for professional development and growth;
• Hybrid work arrangements.