Assoc MDR/Vigilance Spec - Exempt

JOB DESCRIPTION

Top 3 technical skills that are required for the role:

1.Critical Thinking and Analytical Skills

2.Attention to Detail and Documentation Skills

3.Communication and collaboration

Education Required: 4 year degree

Years’ Experience Required: 0-1 year

Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours a week

Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? On site (at least 4 times a week)

What is your timeline for scheduling interviews? In 1-2 weeks

What product line will this person support? Surgical

• Identify and document appropriate complaint categories to assure trend accuracy within the complaint database.
• Writes investigation summaries based on technical product analysis information provided
• Ensures record documentation is maintained in a constant state of audit readiness per internal policies.

• Review, evaluate, classify and perform follow up activities on all product complaints relative to the identity, quality, reliability, safety, and effectiveness of medical devices.
• Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing.

Responsibilities may include the following and other duties may be assigned.

• Processes complaints in the Global Complaint Handling System, supporting the Respiratory Interventions (RI) Operating Unit, according to company policies and regulatory requirements. This may include complaint intake activities, making regulatory decisions, submitting regulatory reports to competent authorities, and providing letters to customers.
• Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
• Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
• Act as liaison with various internal and external complaint handling partners to ensure timely and accurate processing of complaints.
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.