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

Dedalus; Graz; Vor Ort; EUR 54 000 - 65 000; Vollzeit

Zusammenfassung

Join a leading healthcare company as a Pre-Market Quality and Regulatory Specialist in Graz. You'll ensure regulatory compliance and process adherence, contributing to healthcare innovations. Ideal candidates possess a degree, extensive experience in regulated industries, and a strong grasp of healthcare standards.

Leistungen

Flexible working hours

Generous remote work policy

Public transport pass for Vienna

Accident insurance coverage

Language courses and certification subsidies

Qualifikationen

• Minimum 3 years of experience in a regulated industry, preferably in quality management.
• Strong understanding of healthcare quality standards including ISO 13485.
• Mandatory language skills: German, English (upper intermediate or better).

Aufgaben

• Ensuring process adherence for pre-market procedures.
• Completeness of design history files and regulatory submissions.
• Performing internal audits and defending pre-market activities during inspections.

Kenntnisse

Attention to detail

Regulatory conformance

Analytical skills

Project management

Ausbildung

University Degree (Engineering, Computer Science or Science)

Tools

Microsoft Office

Jobbeschreibung

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

Join to apply for the Pre-Market Quality and Regulatory Specialist (m/f/d) role at Dedalus

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

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Join to apply for the Pre-Market Quality and Regulatory Specialist (m/f/d) role at Dedalus

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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

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

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

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Sales and Business Development

• Industries

  IT Services and IT Consulting

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