Compliance Specialist

5 days ago

Central Region, Singapore Adecco Personnel Pte Ltd. Full time $60,000 - $120,000 per year

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The Opportunity

  • Exciting opportunity to work in an organisation manufacturing Medical Devices. You will be ensuring product compliance with Quality and Regulatory requirements throughout development and transfer to production, while maintaining an up-to-date Quality Management System aligned with current regulations.
  • Monday - Friday/ Office Hours
  • Location: MacPherson
  • 6 months contract (Convertible, subjected to performance and business directions)
  • Salary: Up to $5500k (Subjected to experience)

The Talent:

  • Min 2 years of Quality and Regulatory experience in Medical or Pharmaceutical industry
  • Good understanding of US, EU, HSA and other regulations.
  • Competent in communicating with Health Authorities and Authorised Agencies.
  • Internal Audit experience with good knowledge of Singapore, Asia Pacific and European regulatory requirements

Job Description

  • Supports procedures to ensure compliance with Quality Systems and industry regulations during product development
  • Collaborates with cross-functional teams and specification consultants to coordinate regulatory information
  • Educates teams on Quality System requirements and conducts training sessions
  • Monitors and communicates updates on relevant regulations affecting product specifications
  • May handle regulatory filings and maintain documentation required by regulatory bodies
  • Leads QMS/QSR awareness sessions for new hires

  • Establishes and manages Technical Files for low to high-risk medical devices, including:

  • Efficacy and stability data

  • Design history and development
  • Technical construction documentation

  • Risk management and clinical evaluation

  • Essential Requirements checklist

Next Step

Prepare your updated resume, send to the following email:

*Only shortlisted candidates will be contacted*

Amelia Lau An Qi

Direct Line:

EA License No: 91C2918

Personnel Registration Number: R1987023

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