Dedalus Healthcare GmbH

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, both at least B2 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. 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

Weitere Informationen

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 HealthCare GmbH

Human Resources

Monaiser Straße 11a

54294 Trier

https://www.dedalusgroup.de