Head of Qra

Vor 7 Tagen

Dresden, Deutschland Anvajo Vollzeit

*This is anvajo
*

We revolutionize health by enabling prevention, early diagnosis, and close monitoring with our digital platform. Awarded by Focus magazine, anvajo is one of the most innovative employers bringing digitalization and patient orientation to the market. Together we move the world with future-oriented technology from Dresden.

For this we are looking for your active support **at the earliest possible date **

*A typical day
*

As a Head of QRA you will lead our Quality Management & Regulatory Affairs team. You will be responsible for the implementation of and compliance with company-wide ISO 13485 and various international IVD regulations. In addition to preparing reports and communicating closely with our top management, you will be in charge of fulfilling PRRC tasks. Your responsibilities will also include submission of technical dossiers to regulatory authorities in compliance with high quality and regulatory standards for in vitro diagnostic products.

*Your must haves
*
- Personality: pragmatic, structured and goal-oriented approach; communicative character with technical understanding; independent, self-organized and responsible way of working
- Experience: Expertise in compiling & submitting technical documentation according to international regulations, experience as a team lead & PRRC
- Qualification: Diploma or Master degree with technical background, in technical writing, or related areas
- Languages: Fluent in English and German

*Nice to haves
*
- Experience as a Quality Management Representative for medical device companies
- Successfully completed training as a Quality Management Representative according to DIN EN ISO 13485:2016

*Our benefits
*

Personal growth:

- Cooperation in an international & interdisciplinary team
- Exciting projects & responsibility right from the start
- Support with individual further training

Work-life-balance:

- 30 days of vacation
- Flexible working hours
- MyFlextime for additional free time
- Regular team events
- Ergonomic sitting/standing workstations
- JobTicket for public transport
- Water, fruit & coffee specialties for free

Purpose & contribution:

- Contribution to our vision to revolutionize the medical market
- TeamEcho for honest and continuous feedback in the team
- Co-creation of the company values

*

**Contact**:
Eva Rudolph
phone
+49 (0) 351 8547 8403

mobile +49 (0) 151 1434 4922

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