Product Surveillance Analyst

Job not on LinkedIn

July 15

🐊 Florida – Remote

Although this job is listed in Florida, this company may be open to hiring remote in other states.

⏰ Full Time

🟢 Junior

🧐 Analyst

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Artex Risk Solutions

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Finance • Insurance • Risk Management

Artex Risk Solutions is a leader in alternative risk management, providing innovative solutions for both large and small organizations. They specialize in creative risk management strategies that help clients optimize their cost of risk, leveraging expertise in capital solutions, specialty risk transfer, and carrier outsourcing services. With a global presence and a commitment to challenging traditional approaches, Artex aims to empower businesses to make informed risk management decisions and enhance their operational efficiency.

501 - 1000 employees

Founded 1997

💸 Finance

📋 Description

• Support complaint handling / field action activities including initiation, investigation, and closure. • Communicating with vendors, regulators, and customers to ensure that timeliness of goals is met. • Resolve discrepancies in complaint files. • Evaluate product complaint / field action documentation for completeness and consistency. • Analyze historical complaints for consistency in evaluation, documentation, and closure. • Work with leadership to improve and maintain Product Surveillance processes. • Identify and present quality issues with risk-based prioritization. • Develop, maintain, and produce reports from the complaint software application and ERP system. • Execute timely and thorough submission of adverse event reports to United States FDA and Health Canada.

🎯 Requirements

• Bachelor’s Degree and 0-1 years of experience working in a regulated industry such as medical device, pharma, defense, etc. required OR HS Diploma and 4 years’ experience working in a regulated industry such as medical device, pharma, defense, etc. • Experience working with personnel of various skill sets and education levels; ability to interface with personnel across multi-functional departments preferred • Intermediate PC and Microsoft Office skills required. • Above average or advanced Microsoft Excel skills preferred. • Ability to define problems, collect data, establish facts, and draw valid conclusions. • Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements. • Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. • Ability to verbally communicate ideas and issues effectively to other team members and management. • Ability to write and record data and information as required by procedures.

🏖️ Benefits

• Medical, Dental and Vision Insurance • Company-Provided Life Insurance • Voluntary Life Insurance • Flexible Spending Account (FSA) • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness) • Matching 401(k) Retirement Plan • Annual Bonus • Wellness Incentive Program • Free Onsite Medical Clinics • Free Onsite Lunch • Tuition Reimbursement Program • Trip of a Lifetime • Paid Parental Leave • Paid Time Off • Volunteer PTO • Employee Assistance Provider (EAP)