Our client is a leading medical microscopy company that develops and manufactures advanced imaging solutions for healthcare professionals worldwide. Their innovative products enable doctors and researchers to see the smallest details of biological samples and support critical diagnoses and discoveries. We are currently seeking a Quality System Regulatory Affairs Specialist APAC to join the team and support their regulatory compliance efforts in the Asia-Pacific region.
Job Summary: The Quality System Regulatory Affairs Specialist APAC will be responsible for ensuring regulatory compliance of their products and processes in the Asia-Pacific region. This position will collaborate with internal stakeholders and external regulatory bodies to maintain and improve the quality management system, ensure timely product registrations, and facilitate product launch in APAC countries. The successful candidate will have strong knowledge of APAC regulatory requirements and experience in quality management systems.
Key Responsibilities:
- Develop and maintain regulatory strategies for product registration in APAC countries
- Prepare regulatory submissions and documentation for product registrations and renewals
- Work with internal stakeholders to ensure compliance with APAC regulatory requirements, including but not limited to ISO 13485, MDR, and local country regulations
- Collaborate with global regulatory affairs team to ensure alignment and consistency across regions
- Provide regulatory support to product development teams and ensure timely product launches in APAC countries
- Maintain up-to-date knowledge of APAC regulatory requirements and provide guidance to internal stakeholders
- Participate in regulatory audits and inspections as needed
- Conduct training on regulatory compliance and quality management systems for internal stakeholders
Qualifications:
- Bachelor's degree in a scientific or technical field, advanced degree preferred
- Minimum 5 years of experience in regulatory affairs in the medical device industry, with a focus on APAC countries
- Strong knowledge of APAC regulatory requirements, including but not limited to ISO 13485, MDR, and local country regulations
- Experience with quality management systems, including but not limited to QMS implementation and maintenance
- Strong analytical and problem-solving skills
- Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams and external stakeholders
- Ability to manage multiple projects and priorities in a fast-paced environment
If you meet these qualifications and are passionate about contributing to our mission to improve healthcare through advanced imaging solutions, we encourage you to apply for this exciting opportunity!
