Strategic Product Registration Specialist

The role of Regulatory Affairs Specialist is a pivotal position in ensuring the timely registration and marketing authorization of company products.

This ensures a seamless expansion of the product range, thereby driving sales growth.

The successful candidate will be responsible for proactively submitting all necessary registration documents to authorities, streamlining the approval process and propelling innovations to market efficiently.

• Submit all necessary registration documents for new products to authorities, ensuring a smooth and timely approval process.
• Maintain product market presence by ensuring prompt submission and meticulous monitoring of registration renewals, securing regulatory approval without delays.
• Stay ahead of the curve by ensuring timely submissions and approvals for upcoming product variations, allowing adaptability in a dynamic market.
• Keep Product Registration Database up-to-date, providing senior staff with the latest registration statuses, facilitating informed decision-making and strategic planning.
• Stay informed on competitors' registration statuses, using this intelligence to refine strategies and maintain a competitive edge.
• Collaborate with business partners to navigate certification challenges, fostering strong relationships and ensuring seamless certification processes.
• Monitor adverse events for medical devices.

• Higher medical education (diploma in medicine, pharmacy or other health-related disciplines).
• Strong communication skills.
• Strong persuading and influencing skills.
• High personal initiative and achievement motivation.
• At least 3 years of experience in medical device registration function either in a medical device company or registration body.
• High technical/organizational accuracy.
• English and Russian language written and spoken.

A global leader in healthcare, we are driven by a passion to innovate and improve lives. With over 100,000 employees worldwide, we strive to advance science and ensure access to healthcare today and for generations to come. Our innovative approach has resulted in more than 26 million people treated with our medicines and over 30 billion tests conducted using our diagnostics products.