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bioMérieux

RA Specialist

bioMérieux

Posted

3 weeks ago

Bangkok, Bangkok City

Remote

THB 50K

Mid Level

Full Time

Match

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Sema

Sema Summary

As a Regulatory Affairs Specialist at bioMérieux in Bangkok, you will be responsible for ensuring compliance with local regulations for medical devices and diagnostics. You will work on regulatory submissions, maintain documentation, and coordinate with various stakeholders. The role requires a mid-level professional with a strong understanding of healthcare regulations and quality assurance processes. Being a hybrid position allows for flexible work arrangements. Competitive salaries and career growth opportunities are available.

About Company

bioMérieux is a global leader in in vitro diagnostics, focusing on providing diagnostic solutions that improve patient care. The company is committed to innovation and excellence in healthcare.

Core Requirements

  • Bachelor's degree in life sciences
  • Experience in regulatory submissions
  • Strong knowledge of local healthcare regulations
  • Ability to work with cross-functional teams
  • Detail-oriented

Responsibilities

  • Conduct regulatory assessments for products
  • Prepare and submit regulatory documents
  • Maintain compliance with local laws
  • Collaborate with R&D teams on new products
  • Monitor changes in regulations
  • Ensure quality management compliance
  • Assist in audits and inspections

Must Have skills

Regulatory knowledgeProject managementDocumentation skillsCommunication skillsAnalytical skills

Nice To Have Skills

CRM software proficiencyTechnical writingBilingual abilitiesTeam leadershipIndustry networking

Tools Knowledge Requried

Quality management softwareDocument management systemsRegulatory databasesMicrosoft OfficeProject management tools

Job Keywords

Regulatory AffairsComplianceMedical DevicesQuality AssuranceHealthcare Regulations

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