International RA Country Specialist

• Ensure timely completion of the Registration Annual Schedule in assigned countries and report progress according to established Key Performance Indicators (KPIs) to facilitate the introduction of new products and maintain continuous product access to markets.
• Anticipate and communicate regulatory requirements for assigned countries, serving as a Subject Matter Expert (SME) during the implementation of design changes necessitated by country-specific regulations.
• Oversee regulatory strategies for registration and compliance of IGT-D therapies, documenting them in the Regulatory Schedule for assigned countries.
• Supervise the execution of the Regulatory Schedule, fostering a culture of "First-time right" submissions for Registrations, Re-Registrations, and Renewals.
• Conduct professional negotiations and lead meetings with internal and external stakeholders (Marketing, R&D, Markets, Distributors, Sales), escalating significant issues to the RA Regional Manager as necessary.
• Implement a culture conducive to audits readiness.
• Stay informed about the regulatory environment, maintaining information resources, disseminating changes/updates, and assessing potential impacts from new guidance, standards, and regulations.
• Perform regulatory gap analyses, prepare communications for Request for Solutions (RfS) to the Product Safety Review Board (PSRB), and interface with regulatory agencies and distribution partners as needed.
• Identify process optimisations to enhance the International Regulatory Department and implement necessary improvements.
• Engage in continuous learning activities to stay abreast of technical advancements in supported product areas.
• Provide accurate and consistent regulatory recommendations, decisions, and feedback to RA stakeholders, including risk identification and communication.
• Adhere to Quality System procedures to ensure compliance with applicable regulations.
• Maintain proficiency in regional regulatory requirements, developing strategies for more effective interactions with government agencies.
• Assist the Regulatory Affairs Regional Manager in training junior specialist staff and mentor other Regulatory Affairs personnel.
• Perform any other duties as assigned.

A leading medical technology company focused on delivering innovative healthcare solutions to improve patient outcomes worldwide. The company specializes in developing advanced medical devices and equipment for various medical specialities, including diagnostic imaging, patient monitoring, and healthcare informatics.

• A challenging and stimulating work environment with diverse and interesting projects
• You will join a close-knit team of enthusiastic professionals who support and inspire each othe
• High-quality training and guidance
• A competitive salary with attractive secondary benefits, including hospitalization and group insurance, meal vouchers, and a mobile phone subscription.

• Bachelor's degree in a relevant field (preferred: BS, MS, or PhD in Engineering or Science).
• 2~ years of medical device experience with a MS degree, or 3~ years of medical device experience with an BS degree, or 1~ years of Regulatory Affairs experience with a PhD in Engineering/Science.
• Strong communication skills, both written and verbal, including experience in presenting to senior leadership.
• Demonstrated experience in various types of international regulatory submissions.
• Working knowledge of US FDA, ISO 13485, EU MDR, MDS-REQ 1, UDI, and other applicable regional regulations.
• Ability to make timely decisions, even with incomplete information and under tight deadlines.
• Proficiency in PC hardware/software, documentation, and archives (especially Microsoft Office Suite, particularly Word and Excel).
• Fluency in English (written and spoken); knowledge of other languages is advantageous.