Complaints Manager - Salemburg, United States - Stellar Enterprises

Stellar Enterprises

Verified Company

Salemburg, United States

3 weeks ago

Posted by:

Meredith Sinclair

beBee Recruiter

Description

Currently, on behalf of an established medical technology company from southern Bavaria, I am looking for an employee for the area of complaint management (m/f/d).

Our client stands out for its flexible work model and international orientation.
If you are open to a new position in the field of complaint management in the medical technology industry, these would be your tasks:

Your tasks:

* Autonomous provision and processing of technical documentation as well as compilation for commissioning of clinical evaluations

Implementation of MDR-compliant technical documentation for medical devices and ensuring compliance with regulatory requirements according to Regulation (EU) 2017/745 (MDR) and EN ISO 13485:2016
Creation and coordination of biocompatibility tests and biological evaluations according to EN ISO 10993
Documentation of technical product changes in the course of the development process
Support with product registrations in domestic and foreign markets and processing and responding to test reports

Your qualifications:

* Completed training or degree in natural sciences or engineering, ideally in the field of medical technology or a related field

Good understanding of technical documentation in the medical technology industry and extensive knowledge of specific standards and laws (EN ISO 13485:2016, Regulation (EU) 2017/745 (MDR), EN ISO
Strong communication