Job Description
Hello, FDA Freelancer!
Website Ventum Consulting China
With over 19 years as an independent and value-oriented consultancy, we are proud of our growth and our success on the journey into the digital age. Today we have over 150 employees at 5 branches worldwide connecting more than 20 nations. With our understanding of different cultures and economic sectors, not only do we build a bridge between business and IT, but also between today and the digital future.
This is the perfect job for you if you like to:
- be responsible for CE and FDA registration of medical device products
- be responsible for the collection, preparation and submission of product registration information, coordination and rectification until certified
- be responsible for collecting laws, regulations and international standards related to the international registration of products
- connect with testing institutions, follow up the testing progress, coordinate the solution of testing problems, and obtain testing reports
- be responsible for process optimization, focus on business specific issues to promote process improvement, support business efficiency and smooth
- assist R & D departments to interpret regulations
- cooperate with foreign experts to implement CE/MD projects
- review the organizational structure and business processes
Educational requirements:
Bachelor’s degree mandatory, Master’s, or higher desirable. Major in English, biology, medicine or related fields.
What would be ideal to see on your side:
- You are familiar with the EU CE registration process, have more than 2 years of CE product registration experience, completed the complete CE certification process of at least 1 product
- You are familiar with FDA registration process, more than 2 years experience in FDA product registration, complete the complete FDA certification process for at least 1 product
- You understand industry specifications and technical requirements, have rich experience in CE and FDA registration document editing, understand relevant laws and regulations, experience in medical device industry product registration is preferred
- You bring a proficiency in English reading and writing, CET-6 is preferred
- You love the job, have a cheerful personality, a strong communication skill, and complete other work assigned by the company temporarily
What you will find on our side:
- Join us in building the best Cross-X Collaboration Consulting in China
- Provide a platform to help understand FDA regulations, especially cybersecurity related compliance knowledge
- Personal impact: we will shape Ventum together!
Further info
Able to adapt to short-term business trips.