Field Action Manager

Beschreibung

FIELD ACTION MANAGER

Contract until the end of 2013

Solothurn, Switzerland

Salary: Negotiable

- 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 yrs experience in Medical Device or related fields

Knowledge of regulatory environment is a definite plus

LANGUAGES:

English is essential, German is also 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