Job Title: Regulatory Affairs Quality Assurance (RAQA) Executive
Location: Kuala Lumpur, Malaysia
About Us: Our client is a leading medical device company dedicated to improving healthcare through innovative medical devices. Our commitment to quality and regulatory compliance ensures that our products meet the highest standards and positively impact patient lives.
Job Description: We are seeking a highly motivated and detail-oriented RAQA Executive to join the team. In this role, you will be responsible for ensuring that our medical devices comply with all regulatory requirements and maintaining the highest quality standards.
Key Responsibilities:
- Develop and implement regulatory strategies to ensure compliance with local and international regulations.
- Prepare and submit regulatory documents to relevant authorities.
- Monitor and interpret regulatory requirements and communicate changes to the team.
- Conduct internal audits and support external audits to ensure compliance with quality standards.
- Collaborate with cross-functional teams to address quality and regulatory issues.
- Maintain and update quality management systems (QMS) and documentation.
- Provide training and support to staff on regulatory and quality assurance matters.
Qualifications:
- Bachelor's degree in a related field (e.g., Biomedical Engineering, Life Sciences, Regulatory Affairs).
- Minimum of 3 years of experience in regulatory affairs and quality assurance within the medical device industry.
- Strong knowledge of local and international medical device regulations (e.g., FDA, CE, ISO 13485).
- Excellent communication and interpersonal skills.
- Detail-oriented with strong analytical and problem-solving abilities.
- Ability to work independently and as part of a team.
