About the Role

The Regional Quality Assurance role provides oversight for Quality Assurance Programs, Quality Management Systems, processes and procedures to ensure consistency, accuracy, and compliance with regulations, policies and adherence to established standards, including agency, regional, and local guidelines.

Responsibilities

1.1    Ensures business continuity by proactively collaborating with cross‑functional and external stakeholders to maintain regulatory compliance, manage quality risks, and enable uninterrupted supply and market operations.

1.2    Provide oversight of Quality Assurance programs, systems, processes, and procedures to ensure compliance with regulatory requirements, company policies, and applicable standards (global, regional, and local).

1.3    Support internal and external audits and regulatory inspections. 

1.4    Coordinate with regional global teams (e.g. US) to execute corrective and preventive action plans related to field issues.

1.5    Support Supply Chain operations by working with third-party logistics providers and internal warehouses to ensure proper product handling and stewardship. Including value added services (labelling) implementation.

1.6    Collaborate cross-functionally to support new market entries and product launches in the region.

1.7    Deliver quality and regulatory training to internal and external stakeholders as required.

1.8    Maintain an appropriate level of regulatory awareness to ensure QA processes, controls, and records align with evolving regulatory expectations

1.9    Act as a QA partner to Regulatory Affairs by supporting interactions with local regulatory authorities, distributors, and external consultants, particularly on matters related to quality system compliance and regulatory inspections.

1.10    Provide QA support for product registrations, renewals and amendments, including review and approval of quality-related regulatory documentation and evidence

Required Qualifications

1. Required Position Qualifications
2. Bachelor’s degree in scientific discipline, OR
3. Minimum 6 years of experience in healthcare or the medical device industry, OR
4. Bachelor’s degree in non-scientific discipline with at least 3 years of relevant industry experience.
5. Experience with Quality Management Systems (e.g., ISO 9001, ISO 13485)
6. Foundational understanding of applicable regulations and guidelines
7. Strong communication and stakeholder engagement skills
8. Exposure to any of Asia Pacific’s regulation (China (NMPA), Taiwan (GDP, India (CDSCO) and ASEAN markets (preferred).
9. Knowledge of post-market surveillance, vigilance reporting, and medical device recalls
10. Good understanding of medical terminology and anatomy
11. Strong organizational and writing skills, with a direct communication style
12. Ability to work independently and collaboratively across regions and functions
13. High attention to detail and commitment to regulatory compliance and timelines
14. Ability to prioritize and manage multiple tasks and projects
15. Experience with medical device registration, e-submissions, technical documentation, and audits (advantageous)