div>Manage an assigned portfolio of customer accounts across our U.S. and Mexico locations, building relationships via phone and email.
Uline, a family-owned company, is North America’s leading distributor of shipping, industrial, and packaging materials with over 9,800 employees across 14 locations.
p>Actual salary will be based on a variety of factors including relevant internal and external experience, knowledge, skills, scope of job, geographical location or other factors permitted by law . Actively monitor the mailboxes and folders where delivery notes and packing slips are submitted from project sites and enter them into the ERP system.
p>CORA Physical Therapy provides a full range of outpatient services for clients with orthopedic problems, work-related injuries, sport injuries, and neuromuscular and neurological conditions. Works closely and supports operations to deliver digital services and meet patient care and staffing needs.
Provides individual and group ACT services to include, but not limited to, monitoring of daily living activities, assistance maintaining benefits and entitlements, assistance with employment and education, support to manage symptoms, medication observation as requested by physician, advocacy for client’s rights and preferences, assistance accessing resources, family support, coordination of services and care. At Carle Health, we‘re committed to fostering a workplace where every team member feels valued, respected and empowered, where passion and purpose come together to positively impact the lives of our patients and our communities.
Job Description: 5 years of experience in complaint handling, adverse event reporting, MDR evaluation, post-market surveillance, or regulatory affairs within the medical device or pharmaceutical industry. Experience preparing and submitting MDRs through the FDA eMDR portal, including completion of FDA Form 3500A.
5+ years of experience in complaint handling, adverse event reporting, MDR evaluation, post-market surveillance, or regulatory affairs within the medical device or pharmaceutical industry Strong working knowledge of FDA Medical Device Reporting regulations (21 CFR 803) and complaint handling requirements (21 CFR 820.198) Experience preparing and submitting MDRs through the FDA eMDR portal, including completion of FDA Form 3500A Ability to evaluate complaint narratives, determine reportability, and apply FDA coding for adverse events, malfunctions, injuries, and deaths Strong verbal and written communication skills with the ability to collaborate effectively across Quality, Regulatory Affairs, R&D, and Operations teams Experience with quality documentation processes, verification activities, DMR/DMRC documentation, and HIPAA-compliant recordkeeping Proficiency with MS Suite and complaint management systems such as SAP, TrackWise, or similar platforms Bachelor’s degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, Healthcare, or a related field Mission: Support post-market surveillance and regulatory compliance efforts by reviewing product complaints, determining MDR reportability, and ensuring all adverse event submissions are completed accurately and in accordance with FDA requirements, including 21 CFR 803 and Quality System regulations.