Compliance & QA Specialist (Medical Devices/ 6Months/ Up $7k)

Adecco; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A staffing agency is seeking a Quality and Regulatory Specialist in Singapore. This role involves ensuring compliance with quality systems and regulations for medical devices. The ideal candidate has at least 2 years of experience in the medical or pharmaceutical industry, with knowledge of US, EU, and regional regulations. Responsibilities include collaborating with cross-functional teams, conducting training, and managing documentation for regulatory compliance. This position offers a 6-month contract with a salary of up to $7000 based on experience.

Qualifications

• Min 2 years of Quality and Regulatory experience in Medical or Pharmaceutical industry.
• Competent in communicating with Health Authorities and Authorised Agencies.
• Internal Audit experience with knowledge of regulatory requirements.

Responsibilities

• Ensures compliance with Quality Systems during product development.
• Collaborates with teams to coordinate regulatory information.
• Conducts training on Quality System requirements.
• Updates on regulations affecting product specifications.
• Handles regulatory filings and maintains documentation.
• Leads QMS/QSR awareness sessions for new hires.
• Manages Technical Files for medical devices.

Skills

Quality and Regulatory experience

Understanding of US, EU, HSA regulations

Communication with Health Authorities

Internal Audit experience

Job description

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 $7000 (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:

[e-mail]

*Only shortlisted candidates will be contacted*

Amelia Lau An Qi

Direct Line: [phone]
EA License No: 91C2918
Personnel Registration Number: R1987023