Pre Market Quality and Regulatory Specialist; m​/f​/d

Pre Market Quality and Regulatory Specialist (m/f/d) page is loaded## Pre Market Quality and Regulatory Specialist (m/f/d) locations:
DEU - Bonntime type:
Full time posted on:
Posted 9 Days Agotime left to apply:
End Date:
February 22, 2026 (22 days left to apply) job requisition :
JR107087
** Join our Team!
** We are looking for you, located in
** Bonn (Hybrid)
** as a
** Pre-Market Quality and Regulatory Specialist (m/f/d)
**** Your tasks:
*** Ensuring process adherence for the pre-market procedures
* Completeness of design history files and regulatory submissions
* Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams
* Creation and maintenance of key regulatory deliverables of the projects
* Regulatory and CE submissions in cooperation with regional QARA organizations
* Ensuring the adherence to the medical device risk analysis process as risk moderator of the    development team
* Facilitate regulatory compliance in design control processes to ensure that there are no compliance issues during regulatory inspections
* Performing internal audits and defending Dedalus pre-market activities during external regulatory inspections and audits
* Be a QARA ambassador on product teams
** You bring along:
*** University Degree (Engineering, Computer science or Science) or equivalent
* Minimum 3 years of experience in a regulated industry – preferably medical device, pharmaceutical or related – holding a position in project management, quality management, or quality assurance and regulatory affairs position.
* Working independently towards project deadlines and strong attention to detail with the ability to analyse, understand, and interpret regulations and standards for a more general business audience
* Subject matter expert in regulatory affairs with in-depth knowledge of relevant health care quality standards and requirements including ISO 13485, ISO 14971, IEC 62304, IEC 62366, Medical Device Directive, and new Medical Device Regulation MDR and IVDR
* Awareness of Medical Device product safety and Security Standards including ISO 27001, GDPR, and other regulation as determined by product availability (including ANVISA, CMDCAS, FDA, SFDA)
* Expert PC operation skills, including knowledge of enterprise-wide software applications, Microsoft Office applications required (Intermediate to Advanced preferred)
* ** Mandatory language skills, both at least C1 or better:
German, English
***
* What we offer:

*** Permanent employment contract with attractive salary for a long-term perspective
* Flexible working hours and working time models – for a good work-life-balance
* Home office incl. Ticket Plus City  card from Edenred
* Flexitime model
* Innovative workplace with the opportunity to shape the work environment independently and to continuously develop your skills
* Targeted advancement through training and specialist further education
* Up-to-date company cell phone with dual-sim (Android or iOS) also for private use
* Free parking spaces
* Free drinks and weekly fruit basket
* Company pension plan and working time accounts
* Group accident insurance (also valid for accidents during free time)
* Foreign health insurance for business trips
* Regular activities and social events in the team, at the site and in the organization
** Be part of our innovative power and shape the future with us!****#teamdedalus #together4success #dedalusgroup
** We are looking forward to receiving your online application!

Severely disabled applicants will be given special consideration if they are equally qualified.
** Dedalus Health Care GmbH
** Human Resources Monaiser Straße 11a54294 Trier                                     
** We are Dedalus, come join us
**** Dedalus
* * is committed to providing an engaging, rewarding work experience that reflects the passion our employees bring to our mission of helping clinicians and nurses deliver better care to their served communities.

Our company fosters a culture where employees are encouraged to learn and innovate, and to enable and enhance clinical co-operation and processes while making a meaningful difference for millions of people around the world. Each person…