Pre Market Quality and Regulatory Specialist (m/f/d) page is loaded
Pre Market Quality and Regulatory Specialist (m/f/d) page is loaded
Pre Market Quality and Regulatory Specialist (m/f/d) page is loaded
Pre Market Quality and Regulatory Specialist (m/f/d) page is loaded
Dedalus Group
Computer-Software
Bonn
- Art der Anstellung: Vollzeit
- 58.000 € – 79.500 € (von XING geschätzt)
- Hybrid
- Zu den Ersten gehören
Pre Market Quality and Regulatory Specialist (m/f/d) page is loaded
Über diesen Job
Pre Market Quality and Regulatory Specialist (m/f/d)
- locations
- DEU - Bonn
- time type
- Full time
- posted on
- Posted 23 Days Ago
- job requisition id
- JR107087
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 teamFacilitate 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.
Gehalts-Prognose
Bewertung von Mitarbeitenden
Gesamtbewertung
Basierend auf 17 BewertungenVorteile für Mitarbeitende
Unternehmenskultur
Unternehmenskultur
17 Mitarbeitende haben abgestimmt: Sie bewerten die Unternehmenskultur bei Dedalus Group als modern.Dies stimmt ungefähr mit dem Branchen-Durchschnitt überein.