Senior RAQA Specialist, SEA

Businesslist; Kuala Lumpur; On-site; MYR 90,000 - 120,000; Full time

Benefits offered by this job

Basic benefits

Job summary

Businesslist in Malaysia is seeking a Senior RAQA Specialist to lead regulatory affairs and quality assurance for medical devices across SEA. You will develop compliant documentation, coordinate with cross-functional teams, and ensure adherence to evolving regulatory standards.

This permanent role offers involvement in filings, internal audits, and ongoing process improvements, with a strong emphasis on accuracy, collaboration, and proactive problem solving.

Qualifications

• Background in regulatory affairs and quality assurance for medical devices.
• Knowledge of applicable regulatory standards and guidelines.
• Experience preparing and submitting regulatory documentation.
• Strong collaboration and communication with cross-functional teams.
• Excellent organisational and proactive problem-solving skills.

Responsibilities

• Ensure compliance with regulatory standards for SE Asia region.
• Develop and maintain QA documentation and systems.
• Coordinate with cross-functional teams to implement regulatory requirements.
• Monitor regulatory policy changes and update processes.
• Prepare and submit regulatory filings and documentation.
• Conduct internal audits to ensure quality standards.
• Provide guidance on regulatory and quality matters to teams.
• Support continuous improvement of regulatory and quality processes.

Skills

Regulatory affairs

Quality assurance

Cross-functional collaboration

Communication skills

Job description

• Ensure compliance with regulatory standards and guidelines for products and processes across SEA region.
• Develop and maintain quality assurance documentation and systems.
• Coordinate with cross-functional teams to implement regulatory requirements.
• Monitor and assess changes in regulatory policies and update internal processes accordingly.
• Prepare and submit regulatory filings and documentation as needed.
• Conduct internal audits to ensure adherence to quality standards.
• Provide guidance on regulatory and quality matters to relevant teams.
• Support continuous improvement initiatives in regulatory and quality processes.

The Successful Applicant

A successful Senior RAQA Specialist should have:

• A strong background in regulatory affairs and quality assurance within the medical devices industry.
• Knowledge of relevant regulatory standards and guidelines.
• Experience in preparing and submitting regulatory documentation.
• Ability to work collaboratively with cross-functional teams.
• Excellent organisational and communication skills.
• Attention to detail and a proactive approach to problem-solving

What's on Offer

• Basic benefits package included.
• Permanent position in the life sciences industry.

This is a role for professionals in Sea to advance their careers in regulatory and quality assurance.

ContactMichelle LimQuote job refJN-082026-7085535Phone number+603 2302 4057