Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Responsibilities

Responsible for defining regulatory requirements in new product development to ensure design compliance for multiple product lines (both MD and RUO) launching in both China and Global marketConnect with R&D team, manufacturing sites, certification agent, and Registration Department of NMPA, etc for magnificent qualification and certification of new product launchTake ownership of product qualification test until certificate grantedAccountable and responsible for supervising all submission types to Regulatory AuthoritiesInterpret relevant regulations such as industrial standards, and national standards to guide design requirements to R&D team

Qualification

5+ years of work experience in relevant role of regulatory affairsGood understanding of regulatory requirements of instruments (CB, UL, NMPA, etc), preferredGood English language (written and oral) communication skillsGood attention to detail and quality as well as editorial/proofreading skillsGood interpersonal skills to work effectively in a team environmentGood digital literacy including the use of Microsoft Word, Excel, Power Point; capable of learning new technologiesCapable of working independently with direction and exercising independent judgment