Sr. Design Compliance Engr.
Job Description
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 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
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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
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Date Posted
12/24/2024
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