RAQA Specialist - APAC Regulatory Affairs & Quality Assurance

About the role

Applied Medical, a medical device company expanding its APAC presence, is adding to its Regulatory Affairs and Quality Assurance (RAQA) team. The RAQA Specialist supports and maintains regulatory compliance and quality management system (QMS) activities across the APAC region, ensuring medical devices are registered, distributed and maintained in line with applicable regulations and quality standards such as ISO 13485 and Good Distribution Practice of Medical Devices (GDPMD). The role acts as a key liaison between regional commercial teams, global RAQA functions, distributors and regulatory authorities.

Key responsibilities

• Product registrations: obtain approvals from APAC authorities by compiling dossiers according to local medical device regulations, working with the headquarters premarket team, authorities and distributors
• Change management: assess regulatory impacts of product changes, labeling updates and design modifications, and prepare and obtain change approvals in time
• Licence renewals: renew product registrations on time to maintain business continuity
• Post-market activities: process complaints promptly, report adverse events and field safety corrective actions (including recalls) to authorities, and support recall activities
• Local QMS (GDPMD): take part in internal and external audits, manage quality records and documentation, and support QMS implementation in APAC
• Regulatory changes: monitor APAC regulatory changes, perform gap analyses and complete action items
• Maintain regulatory databases, licenses, registrations and records; attend on-site audits as needed

Required profile

• Bachelor's degree in engineering, physical or biological sciences, regulatory affairs or another technical discipline, or equivalent preferred
• 1-2 years of experience in Regulatory Affairs and/or Quality Assurance in the medical device industry
• Training in Quality Systems including GDPMD
• Ability to work independently and in a team, with analytical, meticulous and assertive approach
• Effective oral and written communication and presentation skills

Required skills

• Interpretation of existing and emerging regulations, standards and guidance documents
• Quality systems and regulatory affairs knowledge (GDPMD, ISO 13485)

The position works closely with the Manager, the headquarters RA team and other leadership, and liaises with customers, regulatory agencies, suppliers and internal teams. Benefits follow local labour laws.