Customer Complaints Specialist
4 weeks ago
MillenniumSoft is seeking a highly skilled Customer Complaints Specialist to join our team. The ideal candidate will have a strong background in quality assurance and regulatory compliance, with experience in complaint management and processing of event reporting.
Key Responsibilities:
- Collaborate with clinical, technical, and regulatory employees to determine product event status and MDR reportability
- Assure timeliness and compliance with all FDA regulations and standards related to the review of events/complaints for BD products
- Write and submit eMDR reports to the FDA and Health Canada in strict adherence with regulatory requirements and timelines
- Maintain complaint and MDR file documentation in accordance with regulatory requirements
Qualifications:
- Bachelor's degree in chemistry, engineering, or nursing
- 1-2 years of experience in quality, regulatory, or complaint management
Skills and Abilities:
- Working knowledge of QA, Regulatory/Quality Compliance in a medical device industry
- Attention to detail and ability to utilize computers for development of reports
- Strong proficiency with MS Office tools
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