Please refer to JobSuchmaschine in your application
Compliance Specialist (Life Science)
For one of our client located in Vaud Canton, Switzerland, we are currently looking for aCompliance Specialist.
Responsible for receiving, reviewing, and processing all product inquiries and product complaints for manufactured and distributed products as required by applicable regulations, standards, and company policy.
· Ensure that all complaints are managed/reported accurately, screened for potential safety issues and closed out in a timely manner
· Coordinate with different internal departments (Field Service, Sales, Marketing, Quality, Customer Support, Production) to resolve customer issues.
· Manage customer responses
· Manage complaint files and optimize complaint process.
· Assess potential safety issues and determine incidents to be reported
· Report and communicate with competent authorities within the timeframes.
· Bachelor’s Degree required, preferably in a healthcare related field. Associate’s Degree may be considered with additional years of relevant experience.
· Minimum 2 – 5 years of related experience in the healthcare/device industry or exposure to medical device quality system regulations
· Prior experience processing medical device complaints strongly preferred.
· German and English are mandatory (French is a plus)
· Good Knowledge of Quality Systems (ISO13485, ISO9001)
· Good knowledge of MDD (Medical Device Directive); IVDD a plus
· Knowledge of Vigilance systems (MEDDEV)
· Experience in communicating with competent authorities
· Good customer-communication skills
· Project management skills (follow-up, deadlines…)
· Autonomous and goal-oriented
Your contact at Kelly Scientific Geneva
Stéphane Miras, Senior Branch Director Life Science
Rue du Rhône 114, 1204 Geneva