Straumann

Responsibilities:

1. Regulatory Affairs:
• Responsible for implementing and managing the regulatory activities of medical devices in accordance with MOH (Ministry of Health) registration guidelines, including new product submission, renewal submission, and variations submission.
• Perform regulatory assessments for RA change record and coordinate with legal manufacturer to prepare documents for submission to MOH.
• Ensure timely execution of regulatory strategies as per business plan.
• Ensure product compliance for tender submission.
• Provide regulatory support in tender submission and corresponding inquiry as required.
• Liaise with MOH to ensure products are approved for sale as soon as possible.
• Responsible for sub-labelling, advertising, and promotion activities for regulatory compliance.
• Support IFU translation processes when needed.
• Responsible for database, processes, and systems to manage and maintain all regulatory documents needed for registration, tender application, 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.
• Conduct internal and external audits to assess compliance and identify areas for improvement.
• Manage change controls, CAPA, NC and stop shipment as per requirements.
• Responsible for internal and external audits such as audits from suppliers and support internal audits conducted by HQ.
• 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 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.