Lead Regulatory Affairs Specialist, Hong Kong

The Lead Regulatory Affairs Specialist is responsible for coordinating and handling regulatory affairs in Hong Kong.

• Coordinate and manage regulatory submissions between local company and our own overseas Manufacturers on a timely manner.
• Coordinate and implement the registration process for the company products. Preparation of documentations for regulatory submissions (including new product submissions, change in particulars, tender submissions) to authorities including HK Department of Health, Hospital Authority, etc.
• Act as a bridge between the legal bodies (such as Department of Health, Hospital Authority, and other regulatory agency) and the company. Negotiate with local authorities on behalf of Company objectives.
• Work with our manufacturers to provide strategy and multiple options for meeting regulatory requirements, provide “can do” solutions.
• Write and review Regulatory Submissions as needed.
• Organize electronic database (electronic library) of Regulatory Documents and government notifications on GTW (Global Technical Warehouse).
• Work closely with various internal departments in maintenance of product supply continuity and ensuring regulatory compliance in Hong Kong.
• Create training documents and provide training to our employees to improve regulatory skills in local office or region and at our manufacturers, where applicable.
• Support reimbursement efforts for all submissions where applicable.
• Represent the company as a member of industry organizations.
• Maintain up-to-date understanding of regulatory requirements and trends in Hong Kong, evaluate and anticipate the impact of regulation changes to the company.
• Learn the Group vision for each regulatory submission and become a trusted leader in the organization.
• Have a sound understanding of, and comply with, the COOK Code of Conduct and Company Compliance requirements.

Minimum Work Experience / Educational Requirements:

• Degree in Science, Engineering, Biomedical Engineering or other related discipline.
• At least 8 years solid working experience in regulatory affairs field for medical device or Pharmaceutical industry. Prior working experience in multinational companies is preferred.
• Experience in negotiating with regulatory authorities is preferred.
• Fluent in spoken English, Mandarin and Cantonese & written in English and Chinese.
• Microsoft Office proficiency (Excel, Word, PowerPoint) essential.
• Candidates with less experience will be considered as Senior Regulatory Affairs Specialist.

Personal Attributes: 

• Excellent communication and interpersonal skills. Ability to interact effectively with internal and external stakeholders at all levels and functions across the business.
• Self-motivated, highly organized, able to work with limit supervision and meet deadline.

• Positive working attitude & be good team player.

• Reliable, punctual and dependable.

• Demonstrated ability to meet deadlines, balancing multiple priorities, and ensuring quality standards.

• Analytical approach to problem solving with innovative thinking.
• Approach daily tasks with flexibility, initiative and enthusiasm.

• Ability to follow instructions and take direction.