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 in the target countries.
• Represent the department in Product Development Projects (including medical device software), line extensions and any changes/upgrades of products in the product portfolio to guide and support the organization with regulatory advice for market access.
• 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 FDA and international regulation, guidances and standards applicable to company product

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 USA and Canada markets.
• Experience from working in a medical device industry and have knowledge about ISO 13485 and 21 CFR
• Experience from Medical Device Directive 93/42/EEC and insight into Medical Device Regulation (MDR 2017/745).
• Strong communication skills in English, 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 be located in Mölndal, Sweden and reports 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!