Role Overview

The RAQA Manager, APAC is responsible for overseeing regulatory affairs and quality assurance activities across the Asia‑Pacific region, ensuring full compliance with local regulatory requirements, global standards, and MicroPort quality systems.

This role acts as a key liaison between APAC markets, global headquarters, and cross‑functional teams, supporting market access, product lifecycle management, and quality compliance. The position requires a hands‑on professional with strong regulatory knowledge, quality management expertise, and the ability to operate across multiple countries and regulatory environments.

Job Responsibilities

Regulatory Affairs

Develop and execute regulatory strategies for product registration, approval, and lifecycle maintenance across APAC markets
Lead and manage product registrations, renewals, and variations, ensuring compliance with local regulatory requirements
Monitor regulatory changes and assess their impact on products and business operations
Serve as the key contact with local regulatory authorities, notified bodies, and partners
Support regulatory submissions and documentation, including technical files and product dossiers
Provide regulatory guidance to internal stakeholders on market access and compliance requirements

Quality Assurance

Ensure implementation and maintenance of Quality Management System (QMS) in line with ISO 13485 and applicable regulations
Support internal and external audits, including regulatory inspections and certification audits
Manage non-conformities, CAPA processes, and quality investigations
Oversee complaint handling, vigilance reporting, and post‑market surveillance activities
Ensure product and process compliance with quality standards and regulatory requirements

APAC Regional Support & Coordination

Act as the regional RAQA focal point, working closely with local distributors, partners, and affiliates
Provide operational support for product launches and market expansions across APAC
Coordinate cross‑functional activities with Commercial, Supply Chain, Clinical, and HQ teams
Drive consistency and alignment of RAQA processes across markets

Risk Management & Compliance

Identify and mitigate regulatory and quality risks across the region
Support implementation of risk management frameworks (e.g., ISO 14971)
Ensure adherence to global compliance policies and internal control systems

Qualifications

Education

Bachelor's degree or above in Biomedical Engineering, Life Sciences, Regulatory Affairs, or related field

Experience

8+ years of experience in Regulatory Affairs and/or Quality Assurance within the medical device industry
Strong experience working across multiple APAC regulatory environments
Proven experience in product registration, regulatory submissions, and lifecycle management
Experience supporting QMS and audit activities
Exposure to regional / multinational organisations is preferred

Professional Qualifications

Knowledge of ISO 13485, ISO 14971, and relevant APAC medical device regulations
Regulatory certifications or training are a plus

APAC RAQA Manager