Senior Product Complaint Operations Specialist at United Therapeutics in Rtp, NC

Job description

California, US residents click here . The job details are as follows: Who We Are We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. Who You Are Join a mission-driven team where your quality and compliance expertise directly supports patient safety, product excellence, and global regulatory compliance. As a Senior Product Complaint Operations Specialist, you will be at the center of end-to-end product complaint handling for devices, drugs, combination products, and biologics—helping ensure complaints, MDRs, malfunction reports, FARs, BPDRs, returned goods activities, investigations, and related quality system workflows are managed with accuracy, urgency, and care. This is an opportunity to influence how product complaint processes are executed, improved, and standardized across the product life cycle while partnering with cross-functional teams, vendors, and Brand Safety Leads within the pharmacovigilance function in accordance with EU MDR requirements, combination reporting requirements (21 CFR 820 and 211), IMDRF requirements, ISO 13485 (quality management systems), ISO 14971 (risk management), IEC 62304 (medical device software), and ISO 10993 (biological evaluation). You will develop and deliver meaningful training, apply your medical and technical expertise, support process improvements, and help strengthen a function that has real impact on patients and product quality. If you are energized by solving complex problems, building compliant and efficient processes, and contributing to work that truly matters, this role offers the chance to grow your expertise while making a visible difference. Support day-to-day quality and compliance of end-to-end product complaint handling (entry within the GSD, initiation within UT QMS or other QMS, RGA process, etc.); Maintain unified PC operating procedures and monitor systems to ensure all PCs, MDRs, malfunction reports, FARs, and/or BPDRs are processed and submitted per UT SOPs and industry standards; Support, implement and carry out the overall process and evaluation of PC Handling and/or regulatory changes and support the effectiveness and efficiency of processes for the Product Complaint Intake function for devices, drugs, combination products, and/or biologics at a local and global level across all product life cycles. Develop and deliver training materials and training sessions for product complaint handling in accordance with SOPs, global regulations, guidelines, and conventions; Assist in providing training and/or education in conjunction with the Brand Safety Lead (BSL) and the product FMEAs for the UT product(s) with respect to potential product complaints or user issues t