Complaint Handling & Vigilance Associate (Remote/Flexible)

This Complaint Handling & Vigilance Associate role is integral to supporting the department through data analysis, reporting, trending, and documentation review, coordination of complaint and lot qualification data, device history reviews, and review and closure of certain categories of complaints. It requires organization and attention to detail while working with other functions within the organization to ensure compliance and accomplishment of tasks.

Responsibilities:

• Analyze and process complaints in a uniform and timely manner, to ensure proper complaint coding and accurate complaint assessment.
• Perform data entry and prepare reports / graphs related to special projects, complaints and lot qualification.
• Maintain accurate documentation and files related to special projects, complaints and lot qualification.
• Review and analyze lot documentation (DHR’s) to determine if there are any anomalies that may have related to reported product failures.
• Perform basic product review and failure analysis.
• Support investigation and review of potential adverse events.

• Escalate complex complaint issues as per department policies and guidelines.
• Performs other duties as required.

Minimum Requirements:

• Associate degree or equivalent combination of education and experience with a minimum of 3+ year of experience with data management, record keeping, and trouble shooting in the Medical Device field, or other transferable experience related to organization, technical aptitude, and data management.
 

Preferred Skills and Competencies:

• Effective verbal and technical writing skills. Ability to communicate at multiple levels
of an organization.
• Ability to organize and judge priorities.
• Excels at generating and maintaining organized and accurate records.
• PC skill, word processing, spreadsheet, database.
• Able to work effectively in a high-stress, high-energy environment.
• Able to make decisions quickly based on vague or imperfect information and evaluate the need to obtain clarification and direction when necessary.
Physical Requirements (if applicable):

• This position is a desk job and requires sitting for extended periods of time.

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote 

Additional Information:

The US base salary range for this full-time position is $26.00 - $38.75. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.