Medical Device Quality System & Regulatory Affairs Specialist - Dresden (f/m/d)

Beschreibung

Are you a Specialist for Medical Device Quality System & Regulatory Affairs, ideally looking forward to work in the region of Dresden/Germany? Would you be motivated by working with innovative volume products that helps to save lives? Are you used to working in an international setting and do you have strong communication skills? Then this job opening could be just the thing for you.

SmartResQ ApS is the danish privately held Healthcare & Life Science start-up behind CorPatch®. We create innovative solutions for saving lives. CorPatch® is the first product - a novel and reliable solution to increase survival after cardiac arrest. In SmartResQ we are a team of medical, business and technology experts, who are ambitious and act responsibly with the development of technology and the company based on creative visions and scientific evidence.

We have developed our first products and are expanding our team to industrialize our products for large volume and develop new innovative solutions based on our long-term roadmaps. We are therefore now looking for a motived Medical Device Quality Specialist to join our team.

Your main tasks and responsibilities

Develop and maintain our QM and QA systems according to ISO13485
Corrective and preventive actions, document control, change and risk management, quality management
Prepare and maintain technical documentation according to European medical device regulation (MDR) requirements
Conducting of international approval for medical devices
Support communication with Notified Bodies and Competent Authorities (qualified person)
Represent regulatory affairs on product development and design control to ensure all regulatory requirements are met
Production quality control and Return Merchandise Authorization (RMA)
Point of contact to supplier located in Saxony
Audits - internal and external
Your profile

Engineering degree in either health technology, natural science, electronics or similar domain
Experience in regulatory affairs (MDR) and quality management (ISO 13485) within medical device industry, especially in Medical Apps/BLE is a plus
Understanding of the agile hardware and software development processes
Self-organizing and motivation to drive things forward
Ambitious and hands-on with a can-do mentality
Excellent communication skills – internally and externally
Six-Sigma black belt or similar is a plus
Commercial understanding and interest
English and German language skills on business proficiency level
Ideally interested to join our team in the region of Dresden/Germany
What we offer

Possibility to work with technologies and solutions that save lives
Excellent team spirit in an atmosphere of open and constructive dialogue
Flexibility to work from home office
Long-term stability
Short decision processes
Since we are a start-up, you can expect a lot of work and the possibility to strongly influence the company and your own area of responsibility

Candidates must have a valid European or German permit or work rights to be considered for this position. If you would like to be considered for the role, please apply on the link below with your CV with a short motivation letter, including your target salary and earliest possible date to join our team. All applications are handled 100% confidential and according to GDPR.

In case you have questions or would like a quick assessment of your profile vis-a-vis the job, kindly contact our CTO/COO Thomas Hötzel on mobile +49 178 8727749

We look forward to receiving your application!
https://corpatch.com/career

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