Raqa Specialist

RA/QA Specialist, Malaysia

Main Purpose of the Role

The RA/QA Specialist will be responsible for obtaining medical device pre-market regulatory approval to ensure market access is realized for product portfolio in Malaysia and providing support to maintain the local Quality Management System (QMS) in compliance with Global and local regulatory requirements (if any).

He/She will also handle the sub-labelling, advertisement regulatory activities, and post market regulatory activities i.e. complaint report, product hold, product recall, FSCA, etc.

Responsibilities:

1.

Regulatory Affairs:

• Manage the process of registration and regulatory activities of medical devices in accordance with MDA (Medical Device Authority) registration guidelines, including new product, change notification, special authorisation route, ensuring all regulatory compliance, submission.
• Assume responsibility for Medical Device Establishment/Dealer Licensing with the relevant authorities.
• Handle the maintenance and renewal of Medical Device Registration Certificate.
• Perform regulatory assessments for RA change notification and coordinate with legal manufacturer to prepare documents for submission to MDA.
• Ensure timely execution of regulatory strategies as per business plan.
• Liaise with MDA to ensure products are approved for sale as soon as possible.
• Responsible for database, processes, and systems to manage and maintain all regulatory documents needed for registration and sales.
• Deliver the training of processes, procedures, and work standards/instruction to internal and external stakeholders and ensure the compliance within delegated function.
• Participate in the prediction of the effect of changes in regulations, policies, or procedure.
• Coordinate with other departments i.e. operations, and business unit to support product availability on the market.
• Input and update regulatory milestones in the internal regulatory database as required.
• Escalate any major/critical and urgent regulatory compliance issue in timely manner, whenever applicable.
• Assist in any ad hoc tasks as required.

2.

Quality Assurance:

• Develop, implement, and maintain quality systems, including standard operating procedure (SOP) to ensure compliance with regulations and standards.
• Serves as company Designated Person (DP) for GDPMD (Good Distribution Practice for Medical Devices) Quality Management System.
• Responsible for Quality System documentation including maintenance of accurate and complete records and files.
• Responsible for internal and external audits for company and suppliers, support internal audits conducted by HQ and identify area for improvement.
• Manage CAPA, NC and stop shipment as per requirements.
• Ensure timely reporting of Adverse Events (AE) and Field Safety Corrective Actions (FSCA) as per local regulation.

3.

Training and Documentation:

• Provide training to employees and outsourced service provider on quality management and regulatory requirements.
• Maintain accurate and organized documentation related to quality and regulatory activities.

4.

Continuous Improvement:

• Drive continuous improvement initiatives to enhance quality systems, processes, and overall compliance.
• Stay updated on industry trends, changes in regulations, and best practices in quality assurance and regulatory affairs.

Job Requirements

Education:

Bachelor's degree in Biomedical Engineering (BME), Life Science, Biotechnology or a related field accompanied by relevant experience in medical device.

• Attention to detail, analytical thinking, and problemsolving abilities.
• Excellent communication and interpersonal skills to collaborate with crossfunctional teams and legal manufacturers.
• Good understanding of medical device regulations of other countries such as Australia TGA, CE MDR, Singapore HSA, US FDA and ISO 1348
• Good working knowledge of Microsoft Word, Excel, PowerPoint, and Outlook.
• Proofed experience performing internal/external audits.
• Selfmotivated with good sense of responsibility.
• Solid working knowledge and experience of Vietnam regulations and standards applicable to medical devices market clearance.
• Strong knowledge and experience in the Cold Chain quality management.

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