New opening in Warsaw Office!
We are looking for Junior Regulatory Affairs/Quality Control (RAQC) Specialist, who will be responsible for representing the RAQC function for complaints handling and all Field Safety Corrective Actions (FSCA), including reporting related activities to the Competent Authorities.
Junior RAQC Specialist will assist managers with other QC and RA duties as required, will deal with product registrations and manage loaner pool and consignments stock.
- Monitoring the control plan execution and implementation of FSCA
- Product complaints handling – entering products into Trackwise
- Preparation and distribution of acknowledgement and results letters
- Providing replacement samples to customers and sending complaint samples to the manufacturer
- Supporting manufacturer in obtaining answers to additional questions related to complaints
- Service and repair complaints handling – entering products into Trackwise
- Providing replacement devices to customers and sending broken equipment to the Global Technical Service
- Coordinating plan for electrical safety tests for loaner units
- Managing product hold notices
- Providing trainings for new employees
- Product notifications and re-notifications
- Cooperation with Competent Authorities
- Preparation of WEEE, batteries and packaging reports to authorities
- Working with manufacturer in order to obtain products labelling, certificates or letters required for product notifications and tenders
- Providing support to distributors with regards to regulatory documentation
- Keeping business informed about local regulatory procedures and changes
- Managing loaner pool and inventory stock count
- Preparation of loaner contracts, amendments and updating JDE with loaner equipment moves
- Consignment stock management: inventory stock count, project optimizing stock levels and slow moving items
- Bachelor's degree
- Experience in Regulatory Affairs or Quality Control
- Good knowledge of Act on medical devices
- Demonstrates strong personal ethics and responsibility to purpose
- Must be a strong team player and effectively collaborate with internal departments
- High degree of initiative and independence
- Good written and oral English skills
- Good knowledge of standard software (MS-Office, etc.)
We can offer you a great possibility to work in an international company (first-in-class in its business area), competitive compensation with great benefit package (e.g. health insurance, medical care, lunch vouchers, and sport /entertainment bonus), friendly work environment and healthy oriented culture (healthy food, sport activities, participation in pro-health actions and events, charity initiatives). We are based in a new, modern office in the city center, developed to live healthy lives and to have a great opportunity for professional growth as well as challenging and rewarding work within a dynamic, international teams.
