Job Details

Job Title

Overall experience - 8 to 12 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