Compliance Specialist - QA/ RA (Medical Devices/ 6 Months)

Adecco Personnel Pte Ltd.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading recruitment firm in Singapore is seeking a Quality and Regulatory professional for a 6-month contract role in the medical device sector. The position involves ensuring compliance with quality systems, collaborating with teams on regulatory matters, and educating team members on quality requirements. The ideal candidate has at least 2 years of relevant experience and is knowledgeable about industry regulations. Competitive salary package offered.

Qualifications

• Min 2 years of Quality and Regulatory experience in Medical or Pharmaceutical industry.
• Internal Audit experience with good knowledge of Singapore, Asia Pacific and European regulatory requirements.

Responsibilities

• Supports procedures to ensure compliance with Quality Systems and industry regulations during product development.
• Collaborates with cross-functional teams on regulatory information.
• Educates teams on Quality System requirements and conducts training sessions.
• Monitors and communicates updates on relevant regulations.
• Handles regulatory filings and maintains documentation.
• Leads QMS/QSR awareness sessions for new hires.
• Manages Technical Files for medical devices, including efficacy data and risk management.

Skills

Quality and Regulatory experience

Good understanding of regulations (US, EU, HSA)

Competent communication

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 $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

How to Apply

To apply, please send your updated resume to [e-mail].

*Only shortlisted candidates will be contacted*

An Equal Opportunity Employer