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FH Technikum Wien

Die FH Technikum Wien ist Österreichs einzige rein technische Fachhochschule. Das Ausbildungsangebot umfasst 13 Bachelor- und 17 Master-Studiengänge, die in Vollzeit-, oder berufsbegleitend und/oder als Fernstudium angeboten werden.

FH Technikum Wien Academy

FH Technikum Wien Academy

Die Technikum Wien Academy bietet eine breite Palette an Weiterbildungsmöglichkeiten – vom eintägigen Seminar bis zum postgradualen Master-Lehrgang.

Radio Technikum

Radio Technikum

Radio Technikum ist das neue Wissensradio für Wissenschaft, Bildung und Information im Digitalradiostandard DAB+

Agfa HealthCare GmbH Logo

Quality and Regulatory Professional (M/F)

Branche: Informatik & Wirtschaftsinformatik
Anstellungsart: Vollzeit
Dienstort: Wien
monatl. Mindestgehalt (brutto): € 3.400,00
Beginn der Anstellung: ab sofort

Stellenbeschreibung

For our office in Vienna (alternatively Bonn or Trier) we are looking for a Quality and Regulatory Professional (m/f)

You are responsible for:

  • Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams
  • Definition of regulatory and product quality strategy
  • 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
  • Signing off key project related documentation and milestones
  • Taking actions on process issues for related premarket/design control processes
  • Identify ongoing training needs and provide training as required
  • Performing internal audits and defending Agfa premarket activities during external regulatory inspections and audits

Your Profile:

  • University Degree (Engineering, Computer Science or Science) or equivalent combination of education and experience
  • At least 3-5 years’ experience in a regulated industry – preferably medical device or related – holding a position in
  • quality assurance, regulatory affairs, quality management, or project management
  • 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
  • Operational experience with risk management processes
  • Ability to analyse, understand, and interpret regulations and quality standards for a more general business audience

Specific Skills:

  • Self-starter attitude, strong organizational skills, and the ability to meet deadlines
  • Team player with excellent interpersonal, collaboration, negotiation, conflict resolution, relationship-building, and communication skills
  • Very good German and English verbal and written language skills, French is an asset

We offer a rewarding career in a field that impacts lives, the opportunity to work with a talented, committed team of individuals, training and career development programs, and a competitive compensation and benefits.  (Minimum Salary by law 48.000€ pa.)    Agfa HealthCare GmbH – Astrid Hofmarcher – HR Business Partener - 1150 Wien, Diefenbachgasse 35

Agfa HealthCare GmbH Logo

Agfa HealthCare GmbH

Diefenbachgasse 35
1150 Wien
Österreich