Regional Quality Assurance Associate

We are looking for a Regional Quality Assurance Associate. In this role, you are responsible for ensuring compliance with medical device quality and post-market surveillance regulatory requirements across India and ASEAN markets. This role supports the maintenance of the Quality Management System (QMS), Supply Chain Quality, Post-Market Surveillance (PMS), and regulatory compliance with ISO 13485 and applicable local regulations. Additional responsibilities and regional coverage may change to support business needs within the scope of this position.

Quality Assurance

• →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).
• →Support internal and external audits and regulatory inspections; coordinate with global teams (e.g. US) to execute corrective and preventive action plans related to field issues.
• →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.
• →Collaborate cross-functionally to support new market entries and product launches in the region.
• →Deliver quality and regulatory training to internal and external stakeholders as required.

Post-Market Surveillance (PMS)

• →Coordinate the receipt, investigation, evaluation, and regulatory reporting of medical device incidents.
• →Identify and communicate potential process risks and recommend mitigation actions, collaborate with internal functions and external partners as required
• →Maintain effective quality processes to ensure consistency, accuracy, and reliability in surveillance activities; continuously assess and improve vigilance processes, methodologies, and tools to enhance effectiveness and efficiency.
• →Support PMS projects, including global process improvements and digital enablement of data collection.
• →Promote patient safety through transparent communication, sound decision-making, and appropriate risk management.

Regulatory Support

• →Maintain awareness of applicable regional and international medical device regulations.
• →Liaise with Regional Regulatory Affairs, local regulatory authorities, distributors, and external consultants.
• →Support product registrations, renewals, and variations as needed.

• 3–7 years’ experience in a medical device QA and/or RA role, experience with medical device registrations, e-submissions, technical documentation, and audits is an advantage.
• Hands-on experience with Quality Management Standards (e.g. ISO 9001, ISO 13485).
• Working knowledge of applicable medical device regulations and guidelines.
• Strong communication and interpersonal skills with the ability to work effectively with internal and external stakeholders.
• Exposure to India (CDSCO) and ASEAN regulatory environments is preferred.
• Knowledge of post-market surveillance, vigilance reporting, and medical device recalls.
• Good understanding of medical terminology and basic human anatomy.
• Strong organizational, documentation, and writing skills. 
• Ability to work independently and collaboratively within a diverse, cross-regional team. Flexible and able to manage multiple priorities and projects.
• High attention to detail with the ability to meet regulatory requirements and strict timelines.

 #LI: ASC 

3 bullet points max. List any additional qualifications that are preferred, but not required.