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Quality Engineer, Validation Consultant (English/German)
Eingestellt von ProClinical aus München
Gesuchte Skills: FDA
Projektbeschreibung
This major top-10 Pharmaceutical / Devices Company works in developing innovative medical devices, biopharmaceutical medicines, vetinary products and orthopaedic products. This is a short-term contract (up to 8 months) and the main purpose of the role is about coordinates all the investigations to have documentation ready to decide if there is a product recall.
Skills required:
Follow-up and closing statements about Field Actions to the competent authorities
Central point of contact for the RA in relevant countries as well as internal agencies for assistance to FAs
Communication with non-governmental agencies with respect to FA's
Monitoring of the TG's communication regarding the authorities to FA's
Insertion of a tool for monitoring / tracking of FA's
Knowledge and experience of country-specific requirements for mandatory reporting of FA's
Coordination of communication to authorities with the TG's
Knowledge and execution of the guidelines on code of conduct, ethics and compliance programs and other relevant regulations
Interview process: Telephone interview only
Higher education in Engineering
3-5 years experience in Medical Device
Knowledge of regulatory environment
Urgent position.
To apply, call or send your CV to Laura Brum, Recruitment Consultant – RA / QA
[email protected]
+49 (0)89 12089 5008
+44 (0)207 44 00 638
Skills required:
Follow-up and closing statements about Field Actions to the competent authorities
Central point of contact for the RA in relevant countries as well as internal agencies for assistance to FAs
Communication with non-governmental agencies with respect to FA's
Monitoring of the TG's communication regarding the authorities to FA's
Insertion of a tool for monitoring / tracking of FA's
Knowledge and experience of country-specific requirements for mandatory reporting of FA's
Coordination of communication to authorities with the TG's
Knowledge and execution of the guidelines on code of conduct, ethics and compliance programs and other relevant regulations
Interview process: Telephone interview only
Higher education in Engineering
3-5 years experience in Medical Device
Knowledge of regulatory environment
Urgent position.
To apply, call or send your CV to Laura Brum, Recruitment Consultant – RA / QA
[email protected]
+49 (0)89 12089 5008
+44 (0)207 44 00 638
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Sonstiges