Job Description:

• Work as a regional RA leader to prepare registration strategy, submission plan and coordinate registration submissions in APAC, Thailand, Philippines, Malaysia, Singapore, as well as other south east Asia countries;
• Lead country team and global team to prepare submission dossiers, interact and coordinate the interaction with different health authorities;

• Work as a key contact point for APAC regulatory intelligence, proactively search and monitor policy and regulation changes from health authorities, work with cross functions to analyze the impact of regulatory environment changes to the company’s products and business, and update to key stakeholders timely;
• Overall monitor the registration projects in ASEAN countries, make sure product approvals on time, timely update and report to all stakeholders;

• Review and approve advertising, promotional materials and labeling to ensure regulatory compliance;
• Maintain QMS and certification within the sites, including the the control of quality procedures and records
• Oversee quality processes such as product releases, product re-labelling,  complaint investigations and reporting, change control, non-conformance, correct and preventive actions.
• Monitor 3PLs, suppliers, service providers and distributors with regards to maintenance of product quality and compliance to quality procedures, through regular checks and audits
• Create quality awareness and educate and train employees on the organization QMS, local regulations and certification requirements
• Ensures each site’s audit readiness and manage external regulatory and corporate inspections to ensure full compliance. Coordinate internal audits within the sites
• Escalate critical quality issues and lead any field service corrections / market actions
• Perform post-marketing materiovigilance activities such as reportability assessments for complaints, submission of medical device event reports as required by applicable local laws and regulations, respond to regulatory agencies inquiries on serious Injury and/or Device Malfunction.

Qualifications:

• Bachelor degree or above in life science, engineering or mechanical discipline;
• 8-10 years regulatory affairs experience in MNC, familiar with medical device registration in ASEAN countries, other APAC countries in a plus;
• Good project management and interpersonal skills, team player with the ability to work independently in a fast-paced and dynamic environment;
• Experience of active device registration, laser or RF device registration is a plus, aesthetic device is a plus;
• Basic ISO9001, ISO 13485, GMP and GDP knowledge, auditing Skills (preferred)
• Fluency in written and spoken English, other languages in ASEAN countries is a plus.