Product Compliance Lead

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Experience2-4 years with similar jobs 
ExtentFull time
Work fromOffice and home
StartingBy agreement
Compliance Management
License Applications
Product Compliance
Product Testing
Technical Writing

About the job

As Product Compliance Lead you will ensure that Mindmore’s products comply with all legal regulations and standards for all relevant markets. Furthermore, ensure that all documents are in place to ensure successful and compliant product launches. The role also includes making sure that technical documents and manuals are compliant with regulations. Responsibilities: - Map mandatory compliance requirements and non-regulatory certifications. - Coordinate and track ongoing product testing and certification. - Compile and maintain technical files, establishing and keeping databases. - Identify and monitor worldwide regulatory development. - Make sure that relevant stakeholders are proactively informed. - Take part in new product development projects and product maintenance. - Identify requirements for new market entries. - Support sales and customer service with compliance queries.

Your profile

For this role, we are looking for someone with experience in working with regulatory and compliance-related questions preferably within medical products or fin-tech. You need to have knowledge of mandatory, and voluntary, market requirements to obtain market access in regions worldwide. You have a curious mindset and ability to deep dive into technical product details. We believe you have: - M.Sc. degree in Law, Business/Economics or similar. - Minimum of 4 years of previous working experience in a similar role. - Experience in license applications. - Ability to read and comprehend/interpret medical regulations and create jurisdiction summaries. - Knowledge of global laws, regulations and international standards. - Ability to navigate/interpret ambiguity of standards. It’s a plus if you also have: - Compliance certification knowledge and understanding of EU CE marking process, North American and APAC regulations and voluntary compliance certificate of medical products
Frida Karlsson
Published: May 5, 2022
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