- ค้นหาตำแหน่งงาน
- rayong, thailand
งานใน Rayong, thailand
Specialist Regulatory Affairs & Quality, Thailand & EM
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บริษัท เจ เอ็ม ที เน็ทเวอร์ค เซอร์วิสเซ็ส จำกัด (มหาชน)RayongSpecialist Regulatory Affairs & Quality, Thailand & EM
Zimmer BiometRayong, East, ThailandJOB 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.
Job Summary
Responsible for managing all facets of regulatory support to all Zimmer Biomet segments products. This includes developing regulatory submissions, managing departmental projects, creating and reviewing labelling, providing guidance and consultation for regulations and interacting with government authorities in Thailand and Export Markets (such as Myanmar). An understanding of Zimmer Biomet products and their use as well as an understanding of the regulations, both pre-market and post-market and their application is required.
Principal Duties and Responsibilities
To work closely with regional RA & Global to drive reduction of registration cycle time through Speed to Market initiatives.
- To define and implement product registration approval strategies and plans.
- To manage product approval process and responsible for clearing approval and other barriers to ensure timely market release of new products with appropriate licenses.
- To update significant and comprehensive commentary report on a monthly, quarterly and yearly basis.
Regulatory Operations
Regulatory Compliance
New and Changing Regulatory Environment
Quality
Total Percent (not to exceed 100%)
Expected Areas of Competence (i.e. KSAs)
Education / Experience Requirements
Travel Requirements
What You Can Expect
How You'll Create Impact
What Makes You Stand Out
Your Background
Travel Expectations
EOE / M / F / Vet / Disability