Product Surveillance Manager

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POST DATE 8/19/2016
END DATE 12/19/2016

Confidential Company Warsaw, IN

Warsaw, IN
AJE Ref #
Job Classification
Full Time
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This position is responsible for developing and standardizing the requirements for complaint handling including but not limited to: complaint evaluation and investigation, the filing of Medical Device & Vigilance Reports, the tracking and trending of product quality, the identification, execution, and closure of remedial actions, and other complaint handling activities for the entire Zimmer enterprise in compliance with applicable regulations and guidance requirements worldwide. This individual will stay current with changing regulations and guidance requirements worldwide and provide effective guidance and oversight to all Zimmer locations in dealing with postmarket issues that may arise. This role will interface with all areas of the Company and with all levels of management, globally.

Principal Duties and Responsibilities

Ensures the Corporate complaint handling process is in compliance with applicable regulations and guidance requirement worldwide. Partners with Zimmer sites to ensure compliance across the enterprise.
Ensures product safety issues across the Zimmer enterprise are quickly identified, understood from a patient risk standpoint, and escalated appropriately to ensure proper action and/or agency notification is taken.
Ensures the continuous improvement of product quality and process improvements through the monitoring of post market product quality issues and trends. Ensures quality trend data is disseminated to the appropriate levels of the company for review and action if warranted.
Provides vision, direction, strategy for Corporate complaint handling

Expected Areas of Competence

Ability to work towards in-depth knowledge of Zimmer products, their medical application, and their manufacturing processes.
Ability to answer product-related questions from within the company, the field, and competent authorities worldwide.
Excellent problem solving skills.
Excellent project management skills.
Excellent written, oral, and presentation communication skills.
Detailed knowledge of regulatory authorities (domestic and international), guidance documents and standards.
Detailed knowledge of industry best practices for medical product complaint handling.
Ability to manage ongoing multiple tasks, be responsive to critical situations and changing priorities.
Ability to manage conflict.

Education/Experience Requirements

Bachelor's degreerequired. Prefer course of study in science or engineering. Master's degreepreferred.
6-8years work experience in Regulatory Affairs, Regulatory Compliance, or Post Market Surveillance arena.

Travel Requirements

Up to 20%