Open Position
- Burnsville, MN
Basic Function
This complaint handling specialist position supports all complaint handling and feedback activities. This position interacts closely with the Regulatory and Engineering teams in complaint analysis, investigation, and reporting as applicable. This position is responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.
Apply Now →
Responsibilities
- Ensures timely processing of complaints and feedback while maintaining complaint database
- Collaborates with other departments and leads product complaint investigations
- Writes complaint investigation summaries
- Assists Regulatory team in ensuring all global medical device reports are filed within regulatory timeframes
- Prepares and submits final customer correspondence as required
- Provides training on complaint reporting to other groups
- Performs and presents complaint trending analysis
- Assists with post-market surveillance activities
- Supports inspections by regulatory agencies (e.g. FDA, TUV) as requested
- Perform other related duties and responsibilities, as assigned.
Qualifications
- Bachelor’s degree required
- Minimum of 5 years relevant experience in complaint handling, post market surveillance, quality assurance, or regulatory in medical device or pharmaceutical industry
- Must be able to work independently under limited supervision.
- Knowledge of global regulations for medical device reporting and complaint handling.
- Experience with European Medical Device Regulations, FDA 21 CFR Regulations, Australian TGA Regulations, ISO 14971, ISO 13485.
- Strong communication skills, both verbal and written.
Imricor is an equal opportunity employer and encourages diverse candidates to apply.