RAQA Specialist (Contract)

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Direct message the job poster from Zimmer Biomet

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

Job Summary

This position is responsible to monitor and evaluate the safety, efficacy and performance of Zimmer Biomet’s products. This role is responsible for the post market surveillance from compliance to legislation and working with both the TGA & Medsafe. In addition, Role is responsible for RAQA team activities coordination and managing daily customers requests.

Responsibilities

• Reviewing, evaluation and the investigation of complaints in relation to ZB products
• Work with global and regional teams to ensure all pre- and post market activities are conducted in accordance with relevant legislative requirements
• Manage the channels for Zimmer Biomet representatives to report incidences
• Analyse and report on Post Market trends
• Support PL submission and activities
• RAQA coordinator activities -manage Team meeting and Shared inbox customer requirements
• Review and update regulatory database
• Train sales rep and external supplier on Compliant handling process and requirements
• Prepare and submit all TGA post marketing Reports – such as Custom made- SAS and ACE reports
• Support internal auditing activities
• Working closely with cross functional team on local and global level to ensure continuous supply of ZB products
• Manage the evolving regulatory changes and field notifications

Qualifications

Other information

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