Sr. Design Compliance Engr.

Work Schedule

Environmental Conditions

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 market
• Connect with R&D team, manufacturing sites, certification agent, and Registration Department of NMPA, etc for magnificent qualification and certification of new product launch
• Take ownership of product qualification test until certificate granted
• Accountable and responsible for supervising all submission types to Regulatory Authorities
• Interpret 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 affairs
• Good understanding of regulatory requirements of instruments (CB, UL, NMPA, etc), preferred
• Good English language (written and oral) communication skills
• Good attention to detail and quality as well as editorial/proofreading skills
• Good interpersonal skills to work effectively in a team environment
• Good digital literacy including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
• Capable of working independently with direction and exercising independent judgment