Technical Documentation Specialist

vor 7 Monaten


Hamburg, Deutschland Adaptive Life Science Vollzeit

_Passionate about making a difference in the medical technology industry? _
- Do you love working with technical documentation, in regulatory affairs or quality management?_
- We want to hear from you_

**Overview**:
My client is a leading manufacturer and supplier of high quality ENT treatment units and diagnostic devices for hospitals and private practices, with active customer contacts in over 40 countries.

**Tasks**:

- Create, update, and maintain Technical Documentation for medical devices following MDR guidelines
- Contribute to the design, development, and implementation of new products from a regulatory perspective
- Conduct regulatory reviews of existing products and assist service providers with product changes
- Perform tests on various devices to ensure compliance and approval

**Your Profile**:

- Degree in medical technology, regulatory affairs, or related field
- Familiarity with relevant standards such as MDR, ISO 60601-1, ISO 14971
- Experience in creating and maintaining Technical Documentation for medical devices
- Background in developing medical devices
- Proficiency in CAD software (e.g. SolidWorks)
- Good knowledge of MS Office suite
- Fluent in both spoken and written German and English (B2+ level)
- Result-oriented team player with the ability to work independently and proactively

**Interested?**

+49 30 16639819

Art der Stelle: Vollzeit, Festanstellung

Gehalt: 50.000,00€ - 55.000,00€ pro Monat

Arbeitszeiten:

- Montag bis Freitag

Leistungen:

- Betriebliche Altersvorsorge
- Betriebliche Weiterbildung
- Firmenevents
- Firmenhandy
- Firmenwagen
- Flexible Arbeitszeiten
- Zusätzliche Urlaubstage

Sonderzahlungen:

- 13. Monatsgehalt

Möglichkeit zu pendeln/umzuziehen:

- Hamburg: Problemlos pendeln oder Bereitschaft, mit Unterstützung durch den Arbeitgeber umzuziehen (Erforderlich)

Bewerbungsfrage(n):

- Do you have experience in creating Technical Documentation for medical devices?
- Have you worked with CAD (Computer Assisted Design) software before?

Berufserfahrung:

- Medical Device Regulatory Affairs or Quality Management: 1 Jahr (Erforderlich)

Sprache:

- German (Erforderlich)

Arbeitsort: Vor Ort



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