Regulatory Specialist (Japan + China) from Catapult Staffing

Title: Regulatory Specialist (Japan + China)

Location: Remote

Duration: Multi-year contract (possibility of conversion)

Pay: Up to $50/hr

No C2C/C2H - W2 ONLY

This role is looking for someone with experience specifically with Japanese and Chinese regulations for medical device and drug filings. Your day-to-day will be keeping up with biocompatibility, change product, and risk management. Annual FDA report filings and 501(k) are a must-have for this role.

Responsibilities

• Annual FDA reports
• 501(k) submissions
• Maintaining a deep understanding of new and existing regulations that may impact organizations' products and processes.
• Explaining regulations, procedures, and policies to stakeholders as necessary
• Maintaining data files
• Reporting on compliance status and measures to internal/external parties
• Keeping up with day-to-day standard customer letters, management of change, and product risk management activities

Qualifications

• 3-5 years experience in Regulatory Affairs industry for Medical Devices
• Regulatory device and drug master filing experience
• Regulatory compliance experience
• Regulatory submissions experience
• Medical Device Industry Experience
• Bachelor's Degree