Quality Assurance & Regulatory Affairs Manager

at  EYRIS PTE LTD

WORK EXPERIENCE REQUIREMENTS:

• Minimum 5 years of relevant experience in QA/Tester for Application/software development in medical device industry.
• Qualified lead auditor or ISO 13485:2016 internal auditor, be familiar with ISO 14971:2019, and standards applicable to medical devices and software used for Medical Devices (IEC 62304, IEC 62366)
• Knowledge of applicable regulations for Medical Devices (e.g., 21 CFR 820, EU MDR 2017/745, US FDA 510K, HSA Health Products (Medical Device) Regulations, TGA)
• Hands-on experience in performance testing and functional testing for web application.
• Excellent communication skills to lead/guide the team.
• Strong QA background with experience in identifying details and accuracy in reviewing test plans, test cases and test reports.

EDUCATION LEVEL REQUIREMENTS:

• Bachelor’s Degree/Diploma in a relevant scientific or information technology discipline.

Quality Assurance:

• Lead the QA/RA team on the implementation and maintenance of QMS in accordance to ISO 13485:2016 requirements, and other applicable international standards/regulations.
• Identify gaps in QMS and make continuous improvements to ensure the effectiveness of QMS implementation and consistency with product and process requirements.
• Provide training to staff on QMS procedures and regulatory requirements.
• Oversee document control, ensuring that all quality documentation is accurate, up-to-date, and properly maintained.
• Plan and execute internal and external audit and risk management review accordingly.
• Participate and lead key investigations or issues to prevent recurrence. Responsible in ensuring product reliability through conducting of risk assessments.
• Evaluate and review product on time, implement and conduct investigations in order to formulate corrective actions. Regular reporting and following up to ensure timely closure of CAPA.
• Actively supporting product transfers and ensuring product qualifications and validations of software and processes are established.

Regulatory Affairs:

• Develop and execute regulatory strategies to obtain and maintain product approvals in multiple markets.
• Responsible in the preparation and submission of regulatory filings.
• Maintain regulatory compliance for all marketed products, including post-market surveillance and reporting.
• Monitor changes in regulatory requirements and communicate their impact to the organization.
• Liaise with regulatory authorities and notified bodies as necessary to ensure timely product approvals and renewals.
• Provide regulatory guidance to cross-functional teams, ensuring alignment with regulatory standards.
• Serve as Person Responsible for Regulatory Compliance (PRRC)