Regulatory Compliance Manager

Are you interested in joining an agile team of experts linking medical information to regulatory requirements and ultimately commercial interests within the Dental Implants business? We see this role being strategically important as we can make a difference when it comes to getting our products out on the market.
We are currently looking for a Regulatory Compliance Manager to strengthen our organization. You will work in an international environment with enthusiastic people and continuously develop our business to meet new demanding requirements.
Responsibilities:
• Develop strategies and plans for registration of new or changed products in close cooperation with the registration holders at the Commonwealth of Independent States (CIS).
• Compile registration documentation and manage registration of new / changed products according to the company strategies and plans.
• Review device labeling, labels and advertising material for compliance with regulatory requirements and applicable laws.
• Perform classification of products.
• Maintain current knowledge of Rosdravnadzor registration procedures and the new Eurasian Medical Device Registration Rules (ERR)
Qualifications / Background:
• A MSc in engineering or natural science or an equivalent professional background.
• Experience from writing regulatory applications for medical devices products for entering the CIS market.
• Experience from working in a medical device industry and have knowledge about ISO 13485
• Strong communication skills in English and Russian, both written and spoken.
As Regulatory Compliance Manager in a global business environment, we believe you have analytical skills and enjoy creating creative solutions. You want to be part of shaping an industry and enjoy working together with highly skilled and committed colleagues where every day makes a difference.
The position will primarily be in Mölndal, Sweden but other DS sites could be discussed. The position will report to the Director of Regulatory Compliance. For more information, please contact recruiting manager, Lena Lindblad, telephone +46 72 52 55 751.
Please note that we will review applications continuously, so be sure to send in your CV as soon as possible.
Welcome with your application!