Reg Affairs Specialist

JOB DESCRIPTION

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.

What You Can Expect

Responsible for managing all facets of quality assurance support and quality system processes for Zimmer Biomet Taiwan. This includes ensuring compliance with the corporate requirements, TFDA regulations, ISO 13485 Quality System Standard and other applicable regulations. Able to lead quality improvement projects and resolves problems that have implications beyond own area of responsibility. Require professional expertise and interpersonal skills to manage multiple projects.

How You'll Create Impact

Responsibilities

• Manage all complaint handling, AE, quality field actions, recalls and PMS data collection or reporting in Taiwan. Report to health authorities, APAC or Corporate QA as requested. Prepare monthly updates to Taiwan RAQA Manger and APAC QA.
• Maintain quality files and database to meet / support company and government requirements e.g. transplantation record & feedback form.
• Oversee the Zimmer Biomet Taiwan GTS database and ensure the process implementation, operations are fully compliance with Taiwan local regulations.
• Leads (or co-leads) and participates the external audit by government health agencies, Notified Bodies, authorized third parties and corporate . Manage and support the establishment and maintenance of Zimmer Biomet Taiwan quality system, GDP, QMS procedures, work instructions and records.
• Execute internal audits and monitor quality related operations for continuous quality improvement in Zimmer Biomet Taiwan.
• Responsible for CAPA to ensure complete closures and effectiveness.
• Direct quality improvement projects in Taiwan to ensure alignment with international standards, corporate requirements, local regulations and provides regular communication to Corporate and APAC QA.
• Be knowledgeable of the latest regulatory and corporate requirements concerning quality and quality systems. Update the necessary processes and procedures in Taiwan accordingly, providing regular updates to APAC QA as required.
• Develop effective strategies to cope with issues related to quality assurance.
• Ensure the organization operation is in compliance with corporate and local regulation for quality related.
• Develop and maintain good working relationships with functional areas that support product and quality in Zimmer Biomet Taiwan.
• Support the projects assigned by Taiwan RQA manager.

Your Background

EOE / M / F / Vet / Disability