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

Qualifications :

•Has BSc degree in Life Science or related fields,
•At least 3-years-experience in Regulatory Affairs and R&D departments and has knowledge in country requirements (preferably US FDA also)
•Must have knowledge and experience MDD and MDR requirements (preferably MDSAP also)
•Fluent in English and German
•Has high communication skills
•Using ERP applications and Microsoft Office Programs,

DUTIES and POWERS:

•To conduct the legalization of documents and managing audit for Competent Authority
•To prepare and/ or organize the needed documents for Country Registration process
•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.
•To support for up to date of QMS documentation and attend to the Surveillance Audits by Notified Body and or competent authorities.
•Preparing technical files for the products and, requesting the documents required for the technical file from the relevant departments and ensuring that the technical files are updated.
•To ensure that the packaging materials (package insert, label, box, patient card, etc.) are updated in accordance with the standards.
•To follow up license continuity activities such as license renewal and amendments in the relevant countries and to carry out all necessary communications for the sustainability of the license.
•To ensure that the legislation and standards related to licensing are followed and are compliant.
•the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date.
•To ensure the post-market surveillance obligations

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