Do you want a job with a purpose?

And do you want to make healthcare safer, better and more reliable?

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: German, English (upper intermediate or better)

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. TicketPlusCity 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.