Job opening

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


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.

We look forward to receiving your application!

Please note: Proces Support is supporting the recruitment process, for which reason the job is posted on this page.

Application deadline:
As soon as possible