Product Complaint Manager

Responsible for managing the Post Market Surveillance staff and all related compliance activities associated with the complaint handling program at BSC per corporate, domestic and international standards. Ensure site operational procedures support the corporate policies and guidance while also being aligned with all of the necessary regulations and standards. Your responsibilities will include: Ensures all complaints are reviewed, evaluated, and investigated to determine reportability to FDA and International Regulatory Authorities Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit Initiates and implements corrective and preventive actions when warranted according to the established procedures Coordinates and participates in escalation of adverse complaint trends or product issues Ensure appropriate training is provided to the Post Market Surveillance staff Manages performance and professional growth and development of the staff through the PDC program and per BSC HR policies Evaluates/assesses the developmental/skill needs of staff on a continuous basis to ensure appropriate competencies exist to fulfill business needs Contributes to the development and monitoring of area budget through regular analysis of cost and spending Bachelor's Degree Minimum of 5 years of related work experience or an equivalent combination of education and work experience Knowledge of US and international regulatory authority reporting requirements Experience working with Competent Authorities Strong management and communication skills Project management experience Effective team leadership experience Experience with CRM products Experience with Post Market activities Vendor management experience