What are the responsibilities and job description for the Complaints Handler position at Excelon Solutions?
Compliant Handling Engineers
Alameda, CA
Contract
Job Description :
- Overall experience - 4 to 6 years of Regulatory experience in Medical Devices
- 4 to 6 years of Complaint Handling in Medical Devices
- Responsible for implementing and maintaining the effectiveness of the quality system.
- Identifies and recruits talented staff to support and execute complaint handling activities and on-market support for multiple product lines deemed critical to success of financial performance for the Division.
- Identifies and implements the organizational structure necessary to achieve business objectives and QA compliance within the complaint handling organization.
- Ensures complaints are evaluated against criteria for potentially reportable events and elevated to the medical events group as necessary to meet worldwide medical event reporting requirements.
- Champions and actively participates in development / improvements of complaint handling processes and procedures.
- Monitor incoming complaints for increasing trends and alert management when a product issue is emerging.
- Participate in monthly tracking and trending meetings - provide input on early trends that may not yet be reflected in the data
- Ability to liaison with International Regulatory Authorities
- Ability to write and edit Regulatory / technical documents.
- Problem solving skills.
- Good Communication skills
