Regulatory Affairs Manager (Medical Devices)

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.