This position will work in a team environment with members of Quality focusing on post market surveillance reporting requirements. This position will specialize in evaluating, dispositioning and investigating product reports and identifying complaints as well as managing communications with Inspire field personnel. This individual will also work closely with operations, engineering, sales, marketing and clinical to maintain product report files in accordance with Inspire policies, procedures and other medical device regulations.
The individual for this position must be able to work well in a team environment, foster team building, proactively communicate task status, and operate with a high level of initiative, along with excellent verbal and written communication skills for effective communication with various levels of management.
- Create and evaluate new product reports in accordance with required timelines for escalation, risk, coding and complaint designation.
- Manage product return process, disposition products and ensure return date and disposition status are documented.
- Lead product report and patient follow-up activities and document the results.
- Assist with investigations as assigned and provide returned product kits to field personnel.
- Establish and maintain complete complaint files by updating the product report database with new information and documentation from both field personnel and Engineering.
- Communicate with Inspire personnel to ensure complaints are handled efficiently and effectively.
- Ensure regulatory and compliance requirements related to the complaint system process are fulfilled.
- Run basic complaint handling reports from the product reporting system.
- Compile data for regulatory reports as needed.
- Compose written communications detailing product analysis results to physicians and other end use customers as directed.
- Train various team members on complaint handling process and system.
- Document product and therapy related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.
- Complete training requirements and competency confirmations as required for this position within the required timeline.
- Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.
- Minimum 4 years’ experience in a regulated industry or in a complaint or customer service role
- Proficiency with computer programs including, but not limited to: MS Office (Excel, Word, Outlook, etc)
- Prior experience with medical device complaint handling or regulatory adverse event reporting
- Prior experience in an FDA regulated industry (such as medical device or pharmaceuticals) or ISO certified environment
- Experience as a healthcare provider or in the healthcare industry
- Experience with medical terminology