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

If you are interested in this position opportunity, please send your resume to career@vsybiotechnology.com