• FYTE
Head of Regulatory Affairs

Head of Regulatory Affairs
Permanent - Hong Kong

Job details

  • Function : Public Relations (PR)
  • Sector : Medical Devices
  • Reference : 28633

Job description

A fast growing start up medical devises company is looking for a Head of Regulatory to manage their Company’s regulatory affairs to ensure compliance with applicable rules and regulations while creating competitive advantages in the market for the Company


Job Description

• Implement regulatory strategies to support the Company’s business decisions pertaining to development, production, marketing, and disposal of medical device products throughout their product life cycles. Anticipate changes to the regulatory landscape that may influence the success of the Company’s commercialization endeavors and propose solutions to emerging regulatory problems;
• Liaise with the state-and provincial-offices of the CFDA in China, and relevant regulatory agencies of other countries (if asked), with the aim of developing approaches to expeditious review and approval process for the Company’s products;
• Lead and participate in preparation of submissions for products to regulatory agencies, and work closely with the clinical team of the Company to design and execute clinical and analytical studies required for the regulatory submissions;
• Remain current on regulatory requirements as well as industry trends, and provide related training to the project team on a regular basis;
• Participate as a regulatory expert in quality system and licensing audits;
• Develop regulatory staff members, ensuring that the regulatory team possesses adequate knowledge, experience and talents to meet world-class standards;
• Subject to the Company’s approval on a case by case basis, represent the Company at appropriate professional and trade associations/committees to advance the Company’s standing in the industry;
• Contribute to team effort by accomplishing related tasks as needed;
•Perform other related duties and responsibilities as assigned by the CEO, General Manager or his designate from time to time.
Requirements



• Degree holder in electrical, biomedical or material engineering;
• Familiar with medical device quality management system;
• Excellent communication and interpersonal skills;
• Strong analytical and problem-solving skills;
• Good proficiency in English and Mandarin;
• Willing to travel to Dongguan and other cities in China occasionally;
• Priority given those who have practical experience in medical endoscopic device or surgical robotic system.

Desired profile

-Sound knowledge in medical device regulation, technical standard, familiar with clinical trial procedures and compliance requirement;
-At least 5 years hands-on experience in active medical device registration and project management