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 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. 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. Dedalus
HealthCare GmbH Human Resources Monaiser Straße 11a 54294 Trier
https://www.dedalusgroup.de _____________________________________ 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 is the end point and the starting point of the Group’s
activities and the ultimate beneficiary. For this reason, we are so
proud of doing our very special jobs each day. Our company is enriched
by a diverse population of 7,600 people in more than 40 countries that
work together to innovate and drive better healthcare options for
millions of patients around the world. We are the people of Dedalus.
Our Diversity & Inclusion Commitment sets out Dedalus’ approach to
ensuring respect, inclusion and success for all our colleagues and the
wider communities we operate in. It is imperative for us to share our
commitment and dedication to ensure an inclusive and diverse
workplace. We recognise that we have improvements to make, and, on
this journey, we must remain authentic and realistic but also
ambitious. Our diversity & inclusion commitment – Dedalus Global
Life Flows Through Our Software