Jobbeschreibung
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)
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Ensuring process adherence for the pre-market procedures
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Completeness of design history files and regulatory submissions
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Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams
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Creation and maintenance of key regulatory deliverables of the projects
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Regulatory and CE submissions in cooperation with regional QARA organizations
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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
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Performing internal audits and defending Dedalus pre-market activities during external regulatory inspections and audits
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Be a QARA ambassador on product teams
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University Degree (Engineering, Computer science or Science) or equivalent
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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.
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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
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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
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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)
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Expert PC operation skills, including knowledge of enterprise-wide software applications, Microsoft Office applications required (Intermediate to Advanced preferred)
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Mandatory language skills, both at least B2 or better: German, English
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Permanent employment contract with attractive salary for a long-term perspective
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Flexible working hours and working time models – for a good work-life-balance
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Home office incl. TicketPlusCity card from Edenred
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Flexitime model
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Innovative workplace with the opportunity to shape the work environment independently and to continuously develop your skills
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Targeted advancement through training and specialist further education
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Up-to-date company cell phone with dual-sim (Android or iOS) also for private use
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Free parking spaces
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Free drinks and weekly fruit basket
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Company pension plan and working time accounts
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Group accident insurance (also valid for accidents during free time)
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Foreign health insurance for business trips
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Regular activities and social events in the team, at the site and in the organization