Senior Product Complaints & Compliance Specialist

United Therapeutics Corporation; North Carolina; Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Hybrid work schedule

Medical / dental / vision benefits

401k and ESPP

Job summary

United Therapeutics Corporation is seeking a Senior Product Complaint Operations Specialist to manage end-to-end product complaint handling for devices, drugs, and biologics. You will ensure MDRs, malfunction reports, and related QA workflows are executed accurately and with urgency.

You will develop and deliver training materials, support investigations, and drive improvements across the product lifecycle in collaboration with cross-functional teams and external partners.

Qualifications

• Bachelor’s degree in a relevant discipline is required.
• 5+ years of pharmacovigilance experience in end-to-end case processing and/or product complaint management.
• 3+ years in device and/or combination product experience.
• 2+ years in drug development/postmarketing drug experience.
• Strong knowledge of GMP/GDP/QSR and ISO standards.

Responsibilities

• Oversee end-to-end product complaint handling, MDRs, and related quality system workflows.
• Develop and deliver training on product complaint handling per SOPs and global regulations.
• Support investigations, CAPAs, and vendor-related product complaint activities.
• Coordinate with QA and cross-functional teams to close PCs timely.
• Stay current on global regulations and industry best practices.

Skills

Pharmacovigilance

Regulatory knowledge

MedDRA coding

Project management

Cross-functional collaboration

Analytical thinking

Communication skills

Education

Bachelor’s degree in a relevant discipline

Master’s degree (preferred)

Tools

Argus

Job description

United Therapeutics Corporation is seeking a Senior Product Complaint Operations Specialist to manage end-to-end product complaint handling for devices, drugs, and biologics. You will ensure MDRs, malfunction reports, and related QA workflows are executed accurately and with urgency.

You will develop and deliver training materials, support investigations, and drive improvements across the product lifecycle in collaboration with cross-functional teams and external partners.