Pre Market Quality and Regulatory Specialist

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

_____________________________________

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