Regulatory Affairs 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,
- **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.

Art der Stelle: Vollzeit

Gehalt: 50.000,00€ - 60.000,00€ pro Jahr

Arbeitszeiten:

- Montag bis Freitag

Möglichkeit zu pendeln/umzuziehen:

- 70771 Leinfelden-Echterdingen: bereit sein zu pendeln oder vor Antritt der Stelle einen Umzug zu planen (Erforderlich)

Ausbildung:

- Hauptschulabschluss oder gleichwertig (Wünschenswert)

Berufserfahrung:

- Regulatory Affairs: 2 Jahre (Erforderlich)

Sprache:

- Deutsch / Englisch (Erforderlich)

Arbeitsort: Vor Ort