Product Complaint Analyst II

Your responsibilities will include: Apply clinical and technical knowledge related to product application to evaluate complaints. Investigate complaints by gathering and analyzing data from clinical staff, field representatives, internal employees, and laboratory analysis. Establish regulatory reportability decisions using event investigation tools and decision models. Participate in the development and modification of decision models as product technologies and therapies evolve. Apply appropriate event coding to support product performance tracking, collaborating with engineering, laboratory, and other internal stakeholders to review investigation findings. Bachelor's degree. Minimum of 2 years of experience in a health care, clinical, technical, scientific, or related field. Bachelor's degree in Biology, Health Sciences, Biotechnology, Engineering, or related discipline. Experience with TrackWise or other complaint-handling systems. Experience preparing and submitting MDR, MedWatch, Vigilance, or similar regulatory reports. Experience with SAS or PowerBI is a plus. Strong attention to detail and critical thinking skills. Excellent written and verbal communication skills. Self-motivated, goal-driven, and results-oriented team player. Strong time-management and organizational skills.