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Field Action Manager
Eingestellt von Larson Group
Gesuchte Skills: Engineering
Projektbeschreibung
ROLE: FIELD ACTION MANAGER
LOCATION: ZUCHWIL (SOLOTHURN) AT SYNTHES, SWITZERLAND
RATE: NEGOTIABLE
START DATE: ASAP
ROLE PROFILE:
- Investigation on complaints that have been escalated to become potential field actions
- Leads coordinates all the investigations to have documentation ready to decide if there is a product recall
- Ensuring the appropriate communication of Field Actions to the competent authorities
- 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
- Knowledge and analysis of the local regulatory rules and guidelines
- Documentation of all activities
- Communication with various authorities regarding FA's
- 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
- Substitute to the FA Manager
- Process Owner for "Field Actions" along with the Post Market Risk Manager
REQUIREMENTS:
- Higher Education in Engineering or related fields
- 3-5 years experience in Medical Device or related fields
- Knowledge of regulatory environment is a definite plus
LANGUAGES:
- English - must
- German - desirable
- High Degree of Emotional Intelligence - as you request the work, get things done
- Ability to dealing with high workloads and short timelines
- Perseverance, decision-making ability, communication skills, conflict resolution skills, customer focus, planning ability, assertiveness, team player
LOCATION: ZUCHWIL (SOLOTHURN) AT SYNTHES, SWITZERLAND
RATE: NEGOTIABLE
START DATE: ASAP
ROLE PROFILE:
- Investigation on complaints that have been escalated to become potential field actions
- Leads coordinates all the investigations to have documentation ready to decide if there is a product recall
- Ensuring the appropriate communication of Field Actions to the competent authorities
- 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
- Knowledge and analysis of the local regulatory rules and guidelines
- Documentation of all activities
- Communication with various authorities regarding FA's
- 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
- Substitute to the FA Manager
- Process Owner for "Field Actions" along with the Post Market Risk Manager
REQUIREMENTS:
- Higher Education in Engineering or related fields
- 3-5 years experience in Medical Device or related fields
- Knowledge of regulatory environment is a definite plus
LANGUAGES:
- English - must
- German - desirable
- High Degree of Emotional Intelligence - as you request the work, get things done
- Ability to dealing with high workloads and short timelines
- Perseverance, decision-making ability, communication skills, conflict resolution skills, customer focus, planning ability, assertiveness, team player
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Ingenieurwesen/Technik