Product Surveillance Analyst I (Remote) (Finance)

Requisition ID: 63154 Title: Product Surveillance Analyst I (Remote) Division: Arthrex, Inc. (US01) Location: Remote

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a Product Surveillance Analyst who supports processes including complaint handling, adverse event reporting and field action execution through data analysis, projects, and record review . Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

This position is eligible for remote work.

Essential Duties and Responsibilities:

• 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.

Education and Experience:

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

Machine, Tools, and/or Equipment Skills:

Intermediate PC and Microsoft Office skills required.

Above average or advanced Microsoft Excel skills preferred.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills:

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

Language and Communication Skills:

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.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required sit; use hands and fingers, to handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds.

Vision Requirements:

Visual acuity necessary to do the job safely and effectively.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The area that this job is performed in is a general office or open cubicle/workstation environment. The noise level in the work environment is usually moderate.

Arthrex 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)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.