Post Market Surveillance Consultant I
Minimum 8 years professional experience in the applicable role.
Bachelor's /Master's degree or equivalent.
Demonstrated capability and experience in role. Handle the receipt, processing, monitoring, and reporting of product defect complaints, Make MDR determination, investigate document the all activities creating the summaries of the investigation, Documented product complaints into the database for trending and analysis and ensured the complaint process was completed in accordance with corporate procedures, follow the complaint file all the way until completion, Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
Interfaces with Customer Service and customers/patients to gather additional information required for complaint initiation/investigations, including the retrieval of product samples and or durable equipment retrieval for evaluation, ensures that complaints from multiple sources are tracked. Determines product and incident complaint codes based on the master symptom code severity list.
Applies knowledge of device regulatory requirements in order to support the Post Market Clinical Surveillance reporting process and evaluates complaints for reporting, partners with other departments to resolve product problems and provides feedback to customers as needed, assists with review of the timely coding of completed investigations, closure of all complaint files, and ensures that all pertinent information is contained consistently and uniformly within the file prior to closure, Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.
Reviews and complies with the all applicable company policies and procedures, local, state, and federal laws and regulations. CAPA support in response to audit readiness findings and in preparation for audits. Coordinate initiative to close out overdue Field Change Orders with global markets. Provide team members with training on a variety of assignments. Prepare presentations for weekly management/steering committee meetings.
Thanks and Regards,
APN Software Services, Inc ( www.apninc.com)
39899 Balentine Drive, Suite 385, Newark, CA 94560
Phone: 510-402-1080 / Fax 510-623-5055
Email Id: Sawant@apninc.com