Associate Specialist, Post-market Vigilance - Brampton, Canada - Medtronic

Medtronic

Verified Company

Brampton, Canada

1 week ago

Posted by:

Sophia Lee

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Description

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Reporting to the Manager, Post-Market Vigilance, the Associate Post-Market Vigilance Specialist, has demonstrated adequate technical experience for completing all activities related to the processing of incoming product complaints and the execution of Field Corrective Action (FCA)/Recall activities.

The Associate Specialist is expected, when required, to support efficient and effective complaint handling/recall processes across the Canada region and the Medtronic Operating Units (OU).

This position is responsible for supporting the Manager in meeting Quality Objectives to ensure proper synchronization of workflow across the entire post-market vigilance value stream.

This position will also support the Manager in ensuring consistency with applicable Regulations, Policies, Procedures and Work Instructions.

A day in the life
:

- _Coordinates and/or completes internal/external risk assessments and/or audits and compliance in accordance with regulatory standards, which may include US and/or international regulatory agencies / authorities. _
- _Manages and oversees internal audit activities, which may include conducting and/or overseeing audits, investigations, and/or interviews; and preparing corresponding reports and documents. _
- _May counsel stakeholders about these requirements as necessary. _
- _Ensures compliance with internal and external regulatory agencies, which may include investigating and resolving compliance violations, questions, or concerns. _
- _Analyzes audit data and presents findings to management and/or regulatory bodies in support of Corrective Action Plans, which may include coaching business partners on compliance gaps, data, and/or resulting corrective actions. _
- _Develops and implements programs, communications, and/or training designed to increase employee awareness and knowledge of compliance policies and/or processes. _
- _Responsible for reporting complaints and Adverse Drug Reactions (ADR) _

Supports the company's cell/tissue/organ (CTO), drug, and medical device post

- market vigilance (PMV) programs including all complaint handling and recall activities in compliance with government regulations.

Suggest updates to the Standard Operating Procedures to ensure that they reflect current practices and follow all quality management system, corporate, and local regulatory requirements.
Work collaboratively or in support of the OU/Customer Quality Experience Management in the following complaint handling and recall activities (as applicable and not limited to):
Event Intake, Assessment, and Complaint Determination, Communications (Follow Up, Letters of Analysis, Translation), Review of Investigation/Analysis findings conducted by the Manufacturer, Reportability Decisions, Regulatory Reporting and Regulatory Inquiries, FCA Preparation (Plan Development, Manage Internal Communications), FCA Execution (Manage External Communications, Monitor Execution), FCA Closure & File Maintenance
Ensure the completion of daily work and, when required, active participation in OU working groups (as needed).
Ensure complete and accurate maintenance and reporting of Mandatory Medical Devices Problem Reporting (MDPR)/Error, Accident, Adverse Reactions/Adverse Drug Reaction (ADR) data or adverse reaction data as required by Health Canada.
Ensure complete and accurate maintenance and reporting of 24 Hour Notices, Section 64, Section 65, Foreign Incident Reports (FIR) and Foreign Risk Notifications (FRN) as required by Health Canada.
When required, provide data relevant to the monitoring of data trends and provide analytical support when requested for key metrics/operational reports during periodic review meetings.
Identify/participate in continual process improvement projects related to applicable PMV processes.
When required, partner with upstream and downstream organizations to ensure compliance with all applicable processes and goals across the value stream.
Educate and partner with other organizational stakeholders to suggest improvements to process workflow, develop tools or support system enhancements in alignment with Health Canada requirements.
Ensure high level of quality and consistency in the processing of product complaints and execution of FCA/recalls in partnership with our manufacturers.
Investigate and respond to requests from internal stakeholders and external customers (including Health Canada) related to product performance issues, holds and recalls in a timely fashion.
When required, conduct regular followup correspondence with Health Canada and internal contacts until final closure of the recall file.
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