Danaher Jobs

Job Information

Danaher Corporation RA Specialist in Pudong, China

Purpose/Objective:

  • Responsible for medical device product registration activities in China.

  • Provide support and coordinate with cross-functional team to ensure compliance with applicable regulatory requirements

Job Responsibilities:

  • Be responsible for class I and class II medical devices domestic registration, including product type testing, registration dossier preparation and submission.

  • To ensure all products fully compliance to regulatory requirements.

  • Be responsible for product safety, to ensure all products compliance to UL and TUV standards.

  • To support quality management team for implementing and reporting site activities, including NMPA MDR, Recall and Design Changes.

  • To identify the applicable standards and regulations for products developed in China and train the related team about regulatory requirements if needed.

  • Other tasks assigned by direct line manager.

Person Specification:

  • Bachelor degree majoring in engineering.

  • Familiar with all NMPA class I/II regulations and registration requirements.

  • Familiar with ISO13485 / GMP requirements.

  • Familiar with safety related standards, e.g. GB4793, IEC61010, etc. would be preferred.

  • 23 years of experience in NMPA registration field.

  • 23 years of experience in manufacturing, and medical device industry would be preferred.

  • Good team work spirit and communication skills.

  • Good English and MS office skill.

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.

DirectEmployers