Bruker Corporation

Regulatory Specialist (m/w/d)

Arbeitsort DE-BW-Nehren
Datum der Veröffentlichung 4 weeks ago(6/8/2022 2:05 PM)
Antrags-Nr.:
19524
Anzahl offener Funktionen
1
Positionstyp
Employee
Full Time/Part Time
Full Time

Überblick

Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. As one of the world’s leading analytical instrumentation companies, Bruker develops high-performance scientific instruments and high-value analytical and diagnostic solutions that enable scientists to explore life and materials at molecular, cellular, and microscopic levels. We have been driving innovation in analytical instrumentation for 60 years and today, Bruker continues to build upon its extensive range of products and solutions, its broad base of installed systems, and a strong reputation among its customers. Worldwide, more than 7,200 employees are working on this permanent challenge at over 70 locations on all continents.

Hain Lifescience is a manufacturer and distributor of in-vitro diagnostics. Our customers are medical laboratories worldwide. We are specialists in molecular genetic test systems and technical instruments for the detection of dangerous pathogens or hereditary diseases. Since October 2018, Hain Lifescience has been part of the globally successful technology group Bruker.

Aufgaben/Verantwortlichkeiten

  • Coordination Worldwide of registrations initial, re-registration and amendment registration
  • IVD Reagents, IVD Instruments and IDV Software (EU and non-EU)
  • Ensuring regulatory compliance in the respective target market
  • Preparation and maintenance of registration documents
  • Inter alter creation and maintenance of technical documentation in accordance with 98/79/EG or EU 2017/746
  • Creation of regulatory and approval-related documents e.g. technical dossiers and change notifications
  • Communication with sales partners, authorities and notified bodies
  • articipation in the IVD-Product-Life-Cycle regarding Regulatory aspects: initial development: e.g. Risk Management, Usability, Validation planning, product improvement and product changes.
  • Ongoing assessment of regulatory and normative changes to ensure that our IVD products remain state of the art
  • Close collaboration with R&D, Product Management QM and Sales

Qualifikationen

  • Completed degree in biology, engineers natural sciences, medical technology or comparable qualifications
  • At least 2 years of professional experience in the field of regulatory affairs and/or quality management is an advantage, applications from graduates are also welcome.
  • Knowledge of regulatory standards, guidelines and laws including IVDR and medical device law, DIN EN ISO13485, 21CFR820, DIN EN ISO 14971
  • Goal orientation, commitment, flexibility and ability to work in a team
  • Initiative, independent and structured way of working
  • Communication and organizational skills
  • Fluent English and German skills

Optionen

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