Sr. Design Compliance Engr.

Thermo Fisher Scientific Shanghai, China

Company

Thermo Fisher Scientific

Location

Shanghai, China

Type

Full Time

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

Apply Now

Date Posted

12/24/2024

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