The employee works with the management team to • Oversee quality and legislative requirements of all products and services • Work with contractors and regulatory agencies for product approval and life cycle management • Manage regulatory and technical team
Required Education, Skills and Experience: • Minimum of a bachelor's degree in a life scientific field such as Biochemistry, Biotechnology, Pharmacy, Medicinal chemistry, or Biomedical science • Minimum of 5 years of experience in a similar role • Excellent verbal and written communication skills • Strong problem-solving skills • Highly developed attention to detail • Strong project management skills • Proficiency in Chinese
Essential Functions/Responsibilities
Regulatory Affairs: • Ensuring products in compliance with 510K regulations set by the Regulatory Agency • Composing product, scientific and legal documents • Working with others in the company on various products for technical and regulatory related matters • Planning, undertaking and overseeing 510K clinical trials and FDA regulatory inspections • Keeping up to date with changes in regulatory legislation and guidelines • Obtaining marketing permission • Liaising and negotiating with regulatory authorities • Providing advice about regulations to manufacturers/scientists • Ensuring that quality standards are met, and submissions meet strict deadlines