Based in Hong Kong, at our Asia Pacific Headquarters and reporting to the Senior Regulatory Affairs Manager(Device), Asia Pacific, this position will be responsible for all aspects of regulatory activities for the region, including support of registration applications for assigned medical devices, labeling development / management and regulatory database maintenance.

Key Areas of Responsibilities:

• Prepare, review & advise on documents for regulatory submissions for Asia Pacific countries
• Ensure applications are in line with manufacturers’ and national requirements.
• Tracking applications, make sure progress is made in accordance with commitments and timelines
• Develop, maintain and provide regulatory guidance on labeling, to ensure the compliance with the regulation of local countries and the country of the manufacturer
• Maintain databases for medical device licenses and Asia Pacific specific labeling
• Compile status report for on-going applications
• Provide regulatory input and strategies for product launch and design change
• Provide support to tender applications
• Undertake other ad hoc projects as assigned

Qualifications, Experience and Characteristics Required:

• University graduate in Science or Medical related field
• At least 2 years regulatory affairs experience with drugs and/or medical devices, with multinational companies preferably on a regional basis
• Experience in labeling management is preferred
• Detail oriented and able to work independently
• A team player with good communication and interpersonal skills
• Good command of written and spoken English and Chinese
• Candidates with more relevant experience will be considered as Senior Associate

Please submit your CV with current and expected salary if you are interested.

(Data collected will be used for recruitment purposes only. Candidates should consider their applications unsuccessful if not invited for interview within six weeks.)