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Senior Regulatory Affairs Specialist
hace 1 mes
Cynet Systems is seeking a highly skilled Senior Regulatory Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with country-specific regulations and delivering high-quality product registrations to internal stakeholders.
Key Responsibilities:
- Develop and implement regulatory strategies to ensure compliance with international standards, such as ISO13485 and IEC60601.
- Collaborate with affiliate RAs in different time zones to coordinate project activities and resolve issues.
- Plan and execute tasks proactively, ensuring timely completion and reporting to management.
- Maintain accurate training records and ensure proficiency in internal systems.
- Stay up-to-date with APAC country regulations, including TGA, NMPA, PMDA, MFDS, HSA, TFDA, FDA, and MOH.
- Utilize Agile, SharePoint, MS Office, and other software to increase work efficiency and productivity.
Requirements:
- Bachelor's degree in a relevant field.
- Experience in PAC regulatory submissions in Medical Devices or Pharmaceutical industries.
- Strong knowledge of regulatory affairs and compliance.
- Excellent communication and project management skills.
About Cynet Systems:
Cynet Systems is a leading provider of innovative solutions and services. We are committed to delivering high-quality products and services that meet the evolving needs of our customers.
