Pre Market Quality and Regulatory Specialist

Vor 7 Tagen

Bonn, Deutschland Dedalus Group Vollzeit 60.000 € - 90.000 € pro Jahr
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 B2 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

  • Pre Market Quality and Regulatory Specialist

    Vor 5 Tagen

    DEU - Bonn, Deutschland Dedalus Group Vollzeit 43.500 € - 83.000 € pro Jahr

    Do you want a job with a purpose? And do you want to make healthcare safer, better and more reliable?Join our TeamWe are looking for you, located in Bonn (Hybrid) as aPre-Market Quality and Regulatory Specialist (m/f/d)Your tasks:Ensuring process adherence for the pre-market proceduresCompleteness of design history files and regulatory submissionsRegulatory...

  • Pre Market Quality and Regulatory Specialist

    Vor 6 Tagen

    Bonn, North Rhine-Westphalia, Deutschland Dedalus Vollzeit 80.000 € - 120.000 € pro Jahr

    Do you want a job with a purpose?And do you want to make healthcare safer, better and more reliable?Join our TeamWe are looking for you, located inBonn (Hybrid)as aPre-Market Quality and Regulatory Specialist (m/f/d)Your tasks:Ensuring process adherence for the pre-market proceduresCompleteness of design history files and regulatory submissionsRegulatory and...

  • Pre Market Quality and Regulatory Specialist

    vor 1 Woche

    Bonn, Deutschland Dedalus Vollzeit

    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 aPre-Market Quality and Regulatory Specialist (m/f/d)Your tasks:Ensuring process adherence for the pre-market proceduresCompleteness of design history files and regulatory submissionsRegulatory...

  • Pre-market QAra Professional

    Vor 4 Tagen

    Bonn, Deutschland Dedalus SA Vollzeit

    Vous souhaitez donner du sens à votre métier ? Vous voulez contribuer à l'amélioration de nos soins de santé ? Alors rejoignez notre équipe! We are looking for you in our office in Bonn, Köln, Essen or Home based as a Pre-market QARA Professional (M/F/d) Your Role includes: - You will ensure ongoing Quality and Regulatory compliance of products...

  • Regulatory Affair Specialist

    vor 2 Wochen

    Bonn, Deutschland monipol International Vollzeit

    Regulatory Affair Specialist in regulatory affairs and clinical trials for our office in Germany We are currently looking to recruit a Regulatory Affairs Specialist (RAS) with experience in clinical trials to join our German operations based in our Bonn office. As a Regulatory Affairs Specialist, you will have at least two year of experience in the...

  • Regional Health and Safety Specialist

    vor 1 Woche

    Bonn, Deutschland Siemens Healthineers Vollzeit

    Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Advanced Accelerator Applications, a Siemens Healthineers company, is a global leader in the production of PET radiotracers. With over two decades of expertise, we are committed to delivering high-quality, reliable diagnostic radiopharmaceuticals and services that have...

  • IT Quality Assurance Specialist

    Vor 7 Tagen

    Bonn, Deutschland Dedalus Group Vollzeit 55.000 € - 90.000 € pro Jahr

    Do you want a job with a purpose? And do you want to make healthcare safer, better and more reliable?Join our TeamKaum eine andere Branche entwickelt sich so rasant wie aktuell die IT-Healthcare.Als Dedalus Gruppe sind wir der führende Anbieter von Gesundheits- und Diagnosesoftware in Europa und einer der größten weltweit. Unser innovatives Framework von...

  • IT Quality Assurance Specialist

    Vor 4 Tagen

    Bonn, Deutschland Dedalus Vollzeit 60.000 € - 80.000 € pro Jahr

    Do you want a job with a purpose? And do you want to make healthcare safer, better and more reliable?Join our TeamKaum eine andere Branche entwickelt sich so rasant wie aktuell die IT-Healthcare.Als Dedalus Gruppe sind wir der führende Anbieter von Gesundheits- und Diagnosesoftware in Europa und einer der größten weltweit. Unser innovatives Framework von...

  • Senior Grants Specialist

    vor 2 Wochen

    Bonn, Deutschland ECMWF Vollzeit

    **Your role**: You will be part of the Grants Team, which consists of staff involved in the end-to-end implementation of a particular CfA or Prizes Competition. The Grant Team takes care of the quality assurance of the processes and coordinates and formulates input to the Evaluation Board. It comprises the Call Coordinator and Senior Grants Specialist as...

  • Trainee Focus Public and Regulatory Affairs

    vor 1 Woche

    Bonn, Deutschland Deutsche Telekom AG Vollzeit

    **Your task**: As a young talent with entrepreneurial mindset and the courage to shape the future the "Start up! Traineeprogram" will offer you 18 months to learn and to thrive. After all, we not only want to give you a broad, diverse insight into our organization, but also the opportunity to leave your comfort zone and get to know new topics in order to...