Product Surveillance Associate

Product Safety and Compliance Specialist

Are you ready to make a significant impact by ensuring product safety and compliance on a global scale?

About the Role

The role involves performing technical data assessments of post-market events and supporting quality system activities, ensuring compliance with global regulations. This position is crucial for maintaining the integrity of the organization's quality systems and involves significant interaction with customers, healthcare professionals, and regulatory agencies.

Key Responsibilities

• Field inquiries received by phone, electronic, or verbal correspondence, determine if they qualify as complaints, and document issues according to SOPs.
• Provide technical support and remote troubleshooting guidance as needed.
• Review records independently and contact users and customers to collect information on treatment, product performance, and functionality.
• Conduct periodic follow-ups to close complaints in a timely manner.
• Manage customer relationships and expectations during complaint investigations.
• Complete investigations, including product returns and evaluations, review manufacturing records, and obtain necessary approvals for closure.
• Develop solutions to moderate problems and conduct statistical analysis of complaint trends.
• Support training programs by training users on the complaint process and tools used for assessment and investigation.
• Support and potentially lead investigations related to product deviations, non-conformances, CAPAs, scrap and rework, and analyze data for quality improvement and reporting.
• Update internal operating procedures and specifications through the Document Change process.
• Participate in internal quality system audits and support external audits.
• Evaluate complaints to determine if a Medical Device Report (MDR) or other Vigilance Report is required and support their submission according to regulatory timelines.

Minimum Requirements

• High School Diploma with 4 years of experience OR Associate's Degree with 2 years of experience OR Bachelor's Degree.
• Familiarity with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.
• Basic medical and/or scientific terminology knowledge.
• Highly organized with attention to detail.
• Strong ability to prioritize and manage multiple records/reports simultaneously.
• Professional phone etiquette with the ability to handle sensitive information appropriately.
• Effective communication skills, both written and verbal.
• Proficiency in Microsoft Office Suite.

Preferred Qualifications

• Experience in a medical or surgical office setting.
• Customer service experience.

Physical Requirements

• Must be able to pass vision testing requirements at 20/20 near acuity vision (with or without corrective eyewear).

Work Environment

• Onsite work required with a start time between 7am and 9am CST.
• Standard work week from Monday through Friday with limited overtime.

At Talent Wave Associates, we connect outstanding talent with exceptional opportunities. We're proud to be an Equal Opportunity Employer and are committed to fostering an inclusive, people-first recruiting experience.