Pre-Market Quality and Regulatory Specialist (m / f / d)

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 Graz, Vienna or Bonn (with home office option) 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 : German, English (upper intermediate or better)

What we offer :

Flexible working hours without all-in contracts

Generous remote work policy, including home office equipment

Public transport pass for Vienna and food voucher based on home office ratio

An included accident insurance coverage and discounts for an optional private health insurance

Language courses and certification subsidies (e.g. first aid courses)

Access to a wide range of corporate discounts and additional perks provided by our works council eg. for sports and cultural activities

Be part of our innovative power and shape the future with us!

teamdedalus #together4success #dedalusgroup

The minimum salary for this position is 54.000 € gross per year (38.5 working hours) according to the IT-collective agreement, an overpayment plus bonus arrangement depending on qualification / experience is self-evident for us.

We are looking forward to receiving your online application!

Severely disabled applicants will be given special consideration if they are equally qualified.

Dedalus HealthCare Ges.m.b.H.

Reininghausstraße 13

8020 Graz

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.

Life Flows Through Our Software