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

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.