Posted 2 months ago
This post market surveillance specialist position supports all post market surveillance 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.
- Assists Regulatory team in ensuring all global medical device reports are filed within regulatory timeframes
- Provides training on complaint reporting to other groups
- Performs and presents complaint trending analysis
- Ensures timely processing of complaints and maintains complaint database
- Collaborates independently with other departments and leads product complaint investigations
- Supports inspections by regulatory agencies (e.g. FDA, TUV) as requested
- Makes sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for input from department management
- Uses procedures, judgement, and experience to determine appropriate testing of returned products with minimal guidance.
- Conducts investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints
- Authors post market surveillance plans/reports and periodic safety update reports (PSUR)
- Perform other related duties and responsibilities, as assigned.
- Four-year degree in applicable field
- 5+ years’ experience in Post Market Surveillance
- 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.
To apply, please submit your resume and cover letter documents below.
|Position reports to:||Director of Quality|