QARA Manager

Job Title: Quality Assurance and Regulatory Affairs (QARA) Manager

Location: Singapore

About Us: Our client is a leading innovator in the medical device industry, dedicated to improving patient outcomes through cutting-edge technology and high-quality products. They are committed to excellence, compliance, and continuous improvement in all aspects of our operations.

Job Description: We are seeking a highly skilled and experienced QARA Manager to join their dynamic team. The ideal candidate will be responsible for ensuring that our products meet all regulatory requirements and quality standards. This role involves managing the quality assurance and regulatory affairs functions, including compliance with international regulations, quality system management, and product approvals.

Key Responsibilities:

• Develop, implement, and maintain quality assurance and regulatory compliance programs.
• Ensure compliance with FDA, ISO 13485, and other relevant regulations and standards.
• Lead internal and external audits, including preparation, execution, and follow-up.
• Manage the preparation and submission of regulatory filings and documentation.
• Oversee the development and maintenance of quality management systems (QMS).
• Collaborate with cross-functional teams to ensure product quality and regulatory compliance.
• Provide guidance and training to staff on quality and regulatory requirements.
• Monitor and analyze quality metrics and implement corrective actions as needed.

Qualifications:

• Bachelor's degree in a related field (e.g., Engineering, Life Sciences, Quality Management).
• Minimum of 5 years of experience in quality assurance and regulatory affairs in the medical device industry.
• In-depth knowledge of FDA regulations, ISO 13485, and other relevant standards.
• Proven experience in managing audits and regulatory submissions.
• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Certification in quality management (e.g., CQE, CQA) is a plus.