Regulatory Affairs Assistant Manager

OMRON Group
OMRON Group (Bangkok, Bangkok City, Thailand)
กรุงเทพ, ประเทศไทย 🇹🇭
OMRON Corporation, as a leading company in the field of automation, which features its unique “Sensing & Control + Think” core technology, is engaged in a broad spectrum of businesses, including control equipment, electronic components, social systems, and healthcare. Founded in 1933, OMRON Corporation currently employs approximately 30,000 people and provides products and services in around 120 countries and regions around the world.
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เกี่ยวกับตำแหน่งนี้

The Assistant Manager - Regulatory Affairs will be responsible for the registration/market access process, quality management system establishment and maintenance, and customer satisfaction.

หน้าที่รับผิดชอบ

• Responsible for the registration/market access process to meet product launch schedules and ensure compliance with applicable legislations, organization's policy, and standard operating procedures.
• Create, compile, and manage regulatory filings for product registration, license retention, variation application, and advertisement application.
• Maintain Dealer Licenses for Business Support.
• Establish and maintain GDPMD Quality Management System.
• Participate in post market surveillance activities.
• Monitor and report regulation updates and RA registration status.

คุณสมบัติ

• Bachelor’s Degree in pharmacy, medical device, biology, or related field.
• 4 - 7 years experience in regulatory affairs for medical devices.
• Proficient in English & local language.
• Good knowledge of Microsoft Office.
• Travelling Requirements: As required.

สิทธิประโยชน์

 
   Huneety A.I Salary Estimate
         30,000 - 50,000 THB per month