Regulatory Affairs Specialist

• Compile technical documents to support country-specific regulatory submissions and ensure they are in a format consistent with applicable guidance documents.
• Maintain data and files for future reference, especially in the event of an audit by regulators
• Input and adhere to the scheduling and management of Post Market Surveillance (PMS) plans and reports.
• Review product labels, marketing, and technical documentation to ensure compliance with relevant regulations and technical standards.
• Participate in research of regulatory requirements and disseminate regulatory information to various departments and senior management as required.
• Review product and manufacturing changes are comply with regional regulations and initiate any necessary regulatory submissions.
• Assess device-related incidents/complaints for regional medical device reporting requirements and compile and submit reportable events to relevant regulatory authorities in a timely manner.
• Provide regulatory guidance, ensuring correct interpretation and implementation across the departments for product design, development, evaluation, and marketing.
• Assist in any other ad-hoc duties as assigned.

• Bachelor’s degree in an engineering or science discipline, with a preference for biomedical engineering.
• Minimum 1 year of experience in medical device regulatory affairs, quality, or engineering. Fresh graduates are also welcome.
• Willingness to travel to PRC (People's Republic of China) if required.
• Experience with medical devices is preferred.
• Passion for documentation compilation and review, able to effectively manage multiple projects and priorities.
• Good analytical skills and project management skills, effective interpersonal skills, and the ability to work effectively as a team member.
• Ability to comprehend principles of engineering, physiology, and medical device use.
• Proficient computer skills, including proficiency in Microsoft applications.

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