Primary Job Title :
Postmarket Surveillance Analyst
Alternate / Related Job Titles :
- Medical Device Complaint Specialist
- Quality Compliance Analyst
- Regulatory Reporting Coordinator
Location : Plano, TX
Onsite Flexibility : Onsite
Contract Details :
Position Type : ContractContract Duration : 12 monthsStart : As soon as possibleShift / Hours : Monday – Friday, 8 : 00 AM – 5 : 00 PMJob Summary :
The Postmarket Surveillance Analyst supports regulatory compliance by managing and maintaining complaint files, postmarket surveillance data, and FDA reporting documentation for Class III medical devices. This entry-level position is ideal for professionals with a background in customer service, clinical support, or healthcare quality , seeking to build experience in medical device regulation and quality systems . The analyst ensures data accuracy, process consistency, and compliance with U.S. and international regulatory standards.
Key Responsibilities :
Manage and maintain complaint files in compliance with FDA and company quality system requirements.Collect, analyze, and enter data into postmarket surveillance databases and tracking systems.Assist with regulatory reporting and follow-up investigations for medical device complaints.Coordinate cross-functionally with Quality, Regulatory Affairs, and Customer Service teams to ensure data accuracy.Prepare and review documentation for internal and external audits.Support continuous improvement initiatives related to complaint handling and postmarket quality activities.Provide excellent customer service and communication while adhering to strict confidentiality and regulatory standards.Required Experience :
Up to 1 year of experience in customer service, complaint reporting, or healthcare quality .Experience with FDA-regulated products or medical device complaint handling preferred.Proficiency in Microsoft Office (Excel) and data management systems.Nice-to-Have Experience :
Background in clinical, laboratory, or nursing fields (e.g., LVN, Lab Tech, RN).Experience with SAP or similar ERP systems.Prior exposure to quality systems, CAPA, or regulatory documentation.Required Skills :
Customer service and communication excellence.Strong time management and attention to detail .Proficiency in Microsoft Office Suite (Excel, Outlook, Word).Ability to manage multiple priorities in a deadline-driven environment.Preferred Skills :
Familiarity with medical device postmarket surveillance or quality processes.Analytical mindset with data entry accuracy.Self-sufficient and dependable with strong organizational skills.Education :
Bachelor’s degree required in Biomedical Engineering, Life Sciences, Nursing, or a closely related discipline.Will consider Associate degree holders with 3+ years of relevant coursework or equivalent experience.Recent graduates encouraged to apply.Benefits :
Medical, Vision, and Dental Insurance Plans401(k) Retirement FundAbout the Client :
A global healthcare innovator dedicated to improving lives worldwide. The company’s diverse portfolio spans medical devices, diagnostics, nutrition products, and branded generics , all designed to promote healthier living and better outcomes. Employees collaborate on cutting-edge healthcare technologies that make a difference in millions of lives each day. Join the team and :
Work on innovative global healthcare projectsContribute to regulatory compliance and patient safetyGrow in a diverse, mission-driven environmentBuild a rewarding career with purposeAbout GTT :
GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. As a Native American-owned, economically disadvantaged corporation, we highly value diverse and inclusive workplaces. Our clients include Fortune 500 banking, insurance, financial services, and technology companies, along with major life sciences, biotech, utility, and retail organizations across the U.S. and Canada. We look forward to helping you land your next great career opportunity!
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