Regulatory Affairs and Quality System Executive

Our client is a global Medical Robotics group.

Responsibilities:

• Implement and maintain the companys Quality Management Systems in compliance with ISO 13485 and other relevant regulatory requirements.
• Support the Quality Lead in regulatory activities, including submissions and compliance for new and existing products.
• Assist the Quality Lead in coordinating external audits conducted by notified bodies and regulatory agencies, ensuring timely resolution of any audit findings or observations in collaboration with cross-functional teams.
• Ensure that all quality documents and records adhere to Document Control and Record Control procedures.
• Review and follow up on corrective and preventive actions to enhance quality standards.
• Communicate and liaise with external parties, including suppliers, certification bodies, and consultants.

Requirements:

• Bachelors degree in Life Sciences, Engineering, or a related field.
• 2-3 years of relevant experience, preferably within the medical device industry.
• Familiarity with regulations and requirements for medical devices, including GMP, CE MDR, US FDA guidelines, and ISO 13485 standards.
• Knowledge of Regulatory and Quality Affairs is a plus.
• Self-motivated, meticulous, detail-oriented, and proactive.
• Positive attitude with a strong desire to learn and grow.
• Ability to thrive in a fast-paced environment.

Interested parties, please send the CV to "Apply For Position"/ cv@aral.com.hk.

***Personal data collected will be used for recruitment purposes only***

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