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Lead Regulatory Affairs Specialist
2 months ago
Compensation Range: $55.49/hr - $60.49/hr
Key Responsibilities:
- Oversee regulatory functions, including product approvals and impact evaluations.
- Comprehend and convey country-specific regulations to internal teams, such as product management, engineering, and labeling, for effective product registration and modification strategies.
- Engage in weekly communications with regional Regulatory Affairs teams across various time zones to update on project progress and address challenges.
- Proactively plan and implement assigned tasks within established timelines.
- Provide weekly status updates to management.
- Maintain current training documentation to ensure task competency.
- Be prepared to initiate projects promptly following internal system training.
- Possess knowledge of International Standards, including ISO13485 and IEC60601.
- Understand regulations pertinent to APAC countries, such as TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, and MOH.
- Utilize Agile methodologies, SharePoint, MS Office, and other tools to enhance operational efficiency.
- Exhibit strong time management and project oversight capabilities.
- Experience with regulatory submissions in the Medical Devices or Pharmaceutical sectors.
