
Product Monitoring Specialist
Designs, creates, and verifies/validates routine and ad-hoc data reports regarding various aspects of complaint activities to multiple departments in different locations. Works cross-functionally, identifies and supports the resolution of issues through the coordination of investigations, identification and escalation of adverse trends, and management of complaint and product performance processes. Evaluates complaints for reportability to government agencies (e.g. FDA, TGA, EU Competent Authorities, etc.) and ensures the timely submission of appropriate adverse event reports (i.e. MDRs and Vigilance Reports). Develops trend reports, as well as monthly/quarterly reports on post-market surveillance data. Receives and assesses product complaints, and performs initiation, investigation, analysis, reporting, and closure of complaint records to ensure the program conforms to required regulations and standards. Ensures the product complaint monitoring process remains effective and compliant through development of and participation in continuous improvement programs.
A minimum of 5 years of related experience
Understanding of regulatory topics, including trends in the medical device industry pertaining to compliance.
Experience in responding to inquiries or complaints from customers, regulatory agencies, and members of the business community.
Experience with orthopedic implant products and design preferred
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
MS Word
MS PowerPoint
MS Visio
Time Management Skills
MS Excel skills
Lean manufacturing processes
Verbal communication
written communication
Problem Solving Skills
Flexibility/Adaptability
Detail Oriented and Organized
multitasker
According to JobzMall, the average salary range for a Product Monitoring Specialist in 7475 Lusk Blvd, San Diego, CA 92121, USA is between $50,000 and $70,000 per year. The exact amount may vary depending on the experience level and qualifications of the candidate.
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We believe in advancing the global adoption of less invasive surgery to help patients around the globe suffering from back pain. Through the integration of industry-leading procedures and enabling technologies, we advance the standard of care to help hundreds of thousands of patients each year. Our commitment is to deliver the safest, most efficient technology in the OR to help improve clinical and economic outcomes.

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