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Job Title:  Regulatory Affairs Executive

Location: 

Bangkok, TH

Employment Type:  Agency

 

About OMRON

Founded in 1933, OMRON has come a long way since and has evolved to become an organization committed to creating new social values. Today, In the APAC region, OMRON has a strong presence in Industrial Automation, Healthcare, and Device & Module Solutions. Let’s begin the exciting journey of Shaping Future 2030 together with us!

 

About OMRON Healthcare Business 

With a vision “To advance health and empower people worldwide to live life to the fullest”, OMRON’s Healthcare Business produces internationally acclaimed and certified medical devices such as Digital Blood Pressure Monitors, Thermometers, Nebulizers, devices related to pain and weight management etc. Understand more about our Healthcare Business HERE.

 

Short Description

Job Purpose:

The Executive – RA is responsible for ensuring that all medical devices comply with applicable regulatory requirements and standards in Thailand. This role will prepare and submit the regulatory applications, communicate with relevant authorities, and collaborate with departments to ensure product compliance and market access.

Job Responsibilities:

  1. Ensure medical devices comply with all applicable regulatory requirements and standards
  2. Prepare and submit the regulatory dossiers to relevant authorities
  3. Communicate with regulatory authorities to respond to inquiries
  4. Collaborate with cross-functional teams to execute product strategies (e.g. sales, marketing, and supply chain, etc.)
  5. Monitor and stay up-to-date on changes in medical device regulations
  6. Maintain thorough documentation and records to demonstrate regulatory compliance
  7. Other duties as assigned by supervisor

Job Requirements:

  1. Bachelor’s degree in a relevant field such as Life Sciences, Engineering, or similar.
  2. A minimum of 2 years’ experience in regulatory affairs, with a focus on advertisement applications, preferably within the medical device or pharmaceutical industry.
  3. Having experience in submitting the product registration to other regulatory authorities is an advantage.
  4. Understand the regulatory requirements and quality assurance processes will be a plus.
  5. Proficient in both written and spoken English.
  6. Good knowledge of Microsoft Office (Word, Excel, Adobe, Power Point)
  7. Attention to detail

 

Why Join us

OMRON’s mission is to improve lives and contribute to a better society. We endeavor to make our diverse workforce feel equally valued and enjoy equal opportunities to help us achieve so. So come, work with the best of the best teams, collaborate, and innovate together with diverse, capable minds across the globe.

Req ID:  2991


Job Segment: Quality Assurance, Network, Technology

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