Senior Product Complaint Operations Specialist

United Therapeutics Corporation•RTP, NC, NC

5d•Hybrid

About The Position

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 that could be experienced; use medical/technical expertise to create and provide training Provide quality and compliance support for the designated vendor and associated product complaint workflows, including monitoring activities and assisting with investigation and process requirements, including but not limited to the product complaint workflows/handling, product complaint investigations, maintaining unified product defect investigation operating procedures, maintaining and monitoring systems to ensure that all product complaint investigations received are appropriately investigated and concluded per the company's complaint handling procedure, potentially reportable MDRs, returned goods authorizations, field alert reports, etc. Remain current on global regulations, guidelines and industry best practices for development/non-development programs relating to product complaint handling, product complaint investigations and reporting MDRs Coordinate the product complaint and returns process and collaborate with QA team to achieve the timely closure of the PCs Interface/act as point of contact with external and internal groups, including but not limited to patients, pharmacists, and/or physicians regarding the complaint information necessary for proper complaint investigation Interface/act as point of contact with the Specialty Pharmacies or other 3rd parties suppling return goods authorization for product return for investigation both locally and internationally. Support inspections and audits related to UT GPS product complaint handling activities; assist with root cause analysis of findings and implementation of CAPAs; review deviations and CAPAs as assigned Exercise independent judgment when evaluating compliance issues, safety reporting challenges, inspection observations, and regulatory risks, escalating complex or high-risk matters as appropriate Other duties as assigned

Requirements

Bachelor’s degree in a relevant discipline
5+ years of experience in pharmacovigilance in end-to-end case processing and/or product complaint management with a bachelor's degree, or 3+ years of experience in pharmacovigilance in end-to-end case processing and/or product complaint management with a master's degree
3+ years of device and/or combination product experience
2+ years of product development and/or postmarketing drug experience
Strong written and verbal communication skills, including but not limited to the ability to communicate safety issues in a variety of formats required to meet the needs of the intended audience and contributors
Previous experience using Argus (preferred) or other safety databases
Project management skills and ability to organize and deliver projects and initiatives independently
Working knowledge of drug development processes and activities, including but not limited to having the ability to explain the legislative framework supporting all aspects of Drug Development & registration of medicines, ensuring their safety
Strong analytical thinking to diagnose common situations, gather and review relevant information, and recommend solutions
Ability to work effectively across functions; understands objectives, activities, and required contributions of internal partner functions
Is adaptable and can work effectively in ambiguous situations
Willing and able to challenge current state, suggest alternative approaches to improve work practices, and commit to defined changes
Working knowledge of MedDRA coding
Strong working knowledge of global regulations, guidelines, and industry best practices related to end-to-end case management and product complaint handling for devices, combination products, biologics, and drug products

Nice To Haves

Master’s degree in a relevant discipline
Product development and/or post-marketing drug experience

Responsibilities

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 that could be experienced; use medical/technical expertise to create and provide training
Provide quality and compliance support for the designated vendor and associated product complaint workflows, including monitoring activities and assisting with investigation and process requirements, including but not limited to the product complaint workflows/handling, product complaint investigations, maintaining unified product defect investigation operating procedures, maintaining and monitoring systems to ensure that all product complaint investigations received are appropriately investigated and concluded per the company's complaint handling procedure, potentially reportable MDRs, returned goods authorizations, field alert reports, etc.
Remain current on global regulations, guidelines and industry best practices for development/non-development programs relating to product complaint handling, product complaint investigations and reporting MDRs
Coordinate the product complaint and returns process and collaborate with QA team to achieve the timely closure of the PCs
Interface/act as point of contact with external and internal groups, including but not limited to patients, pharmacists, and/or physicians regarding the complaint information necessary for proper complaint investigation
Interface/act as point of contact with the Specialty Pharmacies or other 3rd parties suppling return goods authorization for product return for investigation both locally and internationally
Support inspections and audits related to UT GPS product complaint handling activities; assist with root cause analysis of findings and implementation of CAPAs; review deviations and CAPAs as assigned
Exercise independent judgment when evaluating compliance issues, safety reporting challenges, inspection observations, and regulatory risks, escalating complex or high-risk matters as appropriate
Other duties as assigned