Compliance Governance Officer coordinating compliance processes and supporting training at Zurich. Engaging in data analysis and ensuring regulatory compliance in financial services.
About the role
- Lead regulatory affairs function for Arthrex in China, focusing on global compliance and strategy. Manage regulatory submissions and collaborate with international teams on product registration.
Responsibilities
- Lead regulatory affairs function for Arthrex China.
- Leads the formulation of registration strategies for products/projects.
- Maintains a high level of regulatory knowledge on global regulatory requirements (NMPA, FDA, EU, etc) and provides regulatory guidance for Arthrex China and global counterparts.
- Acts as core point of contact to NMPA and relevant authorities/external organizations (test labs, CROs, NBs, etc) for products/projects.
- Independently leads the preparation, coordination or monitoring of regulatory submissions.
- Responsible for managing an effective quality system.
- Provides regulatory affairs representation on project teams and lead China RA teams.
- Plans and controls the annual budget for RA department.
Requirements
- Bachelor’s Degree required, preferably in a Science or Engineering discipline.
- Minimum of 10 years’ experience in the position of regulatory affairs and quality domain, and 5 years’ experience in the RA/QA management role
- Strong interpersonal and influencing skills as well as analytical/Statistical skills
- Experience with working with cross-functional teams
- Strong understanding of GMP requirements is an advantage.
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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