Regulatory Affairs Leader - ARC
On-siteMadison, Wisconsin, United States or Wuxi, Jiangsu, China
Job Summary
Provide regulatory leadership and strategic direction for ARC programs, including global support for registration planning, submissions, notified body audits, and program implementation. Develop strategies to optimize submission pathways by analyzing regulatory requirements, product claims, and country dependencies. Review and approve advertising materials to ensure consistency with approved claims, while researching and integrating background information for submissions. Manage premarket and post-market compliance, including product labeling and reporting, and assess changes to determine needs for new or revised licenses. Contribute to writing and editing technical documents, communicating complex information clearly to diverse audiences.
Required Qualifications
- advanced experience in the Quality & Regulatory Affairs
- Knowledge level is comparable to a Bachelor's degree from an accredited university or college
- Minimum of 3 years experience working in a regulated field
- Strong communication skills in English (both written and oral)
- Ability to work independently in fast-paced environment and adapt to change
- Ability to prioritize information for data analysis and recognize when additional information and support is needed
- Attention to Detail and Results-Oriented
- Ability to understand technical documentation and execute associated procedures
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