PMS Specialist - French and English speaking - Oustanding reputation C
Nr ref.: /JOBS.pl
Key Responsibilities Supporting the complaint handling process including: ? Document and coordinate the investigation of product performance issues ? Coordinate and/or perform complaint investigation, ensure related follow-up activities and document investigation findings and results ? Follow up on outstanding evaluations to ensure timeliness and regulatory compliance. ? Monitor customer complaints and provide immediate feedback to concerned personnel when critical issue is detected. ? Maintain complaint tracking system ? Attend/facilitate meetings to resolve Customer Complaints ? Ensure effective CAPA is taken to help prevent reoccurrence
Supporting the Field Action process including: ? Ensuring appropriate recall activities are documented, approved and communicated to relevant parties ? Preparation and obtaining approval of Field Safety Notices, Field Safety Corrective Action Forms in conjunction with the Coordinating Competent Authorities along with Management. ? Collaboration with appropriate personnel to translate the field correction communication and issue of same to Regulatory Authorities with their regions along with consignees. ? Coordination of the final disposition of any returned affected product ? Compilation and Archiving of all records' associated with the Field Action activity • Provide support for the risk management process and provision of complaint data to risk management groups.
Essential Skills / Experience • Engineering/Science qualification with 2/3 years of working within complaints in a medical device environment. • Fluency in French language essential • 2/3 years experience in vigilance reporting - essential • Excellent technical writing experience within a medical device environment - essential • Good working knowledge of the Quality System Regulations as they pertain to customer complaints. • Problem solving skills for developing creative solutions and meeting objectives are required. • Excellent analytical ability • The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management. #
For more information, please contact Marine Dollat at :