Regulatory Affairs Specialist, Stuttgart, Germany

OPEN POSITION: REGULATORY AFFAIRS SPECIALIST / SENIOR SPECIALIST

Reporting to: GM and Global QRM
Proxy for this Position: Quality Specialist / Senior Specialist

Assure the design, development, and preparation of all regulatory files for the registration of products in different countries, including international and European approvals of our own medical devices.

Qualifications:

1. BSc degree in Life Science or related fields.
2. At least 3 years of experience in Regulatory Affairs and R&D departments with knowledge of country requirements (preferably US FDA).
3. Knowledge and experience with MDD and MDR requirements (preferably MDSAP).
4. Fluent in English and German.
5. Strong communication skills.
6. Experience using ERP applications and Microsoft Office Programs.

DUTIES and POWERS:

1. Conduct the legalization of documents and manage audits for Competent Authority.
2. Prepare and/or organize the necessary documents for the Country Registration process.
3. Ensure the conformity of the devices is appropriately checked in accordance with the quality management system (QMS) under which the devices are manufactured before a device is released.
4. Support the updating of QMS documentation and attend Surveillance Audits by Notified Bodies and/or competent authorities.
5. Prepare technical files for the products, request documents required for the technical file from relevant departments, and ensure that the technical files are updated.
6. Ensure that packaging materials (package insert, label, box, patient card, etc.) are updated in accordance with the standards.
7. Follow up on license continuity activities such as license renewal and amendments in the relevant countries and carry out all necessary communications for the sustainability of the license.
8. Ensure compliance with legislation and standards related to licensing.
9. Maintain and update technical documentation and the EU declaration of conformity.
10. Ensure post-market surveillance obligations are met.

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