Intellectt INC
Location
Alameda, CA | United States
Job description
- Deal with APAC countries; APAC experience is desired.
- Regulatory submission exp, Writing submission, doing assessments.
- Medical device exp required.
- Responsible for regulatory activities, including product registrations, impact assessment.
- Understand country-specific requirements and deliver those to internal stakeholders, including product management, engineering, labeling, etc., for product registration and change planning.
- Communicate weekly with affiliate RAs in different time zones to catch up on ongoing projects and discuss the issues to solve.
- Chinese or Japanese proficiency is a plus.
- Must be flexible on time as they will be working with RAs around the globe. Open to taking occasional night calls (after 5PM) with Affiliates.
Education and Experience:
- Bachelor's required with 5+ years of experience.
- Open to a Master with 3+ years experience.
Top Skills:
- Understand technical sections (risk management, product change control, biological evaluation). Must know how to read and interpret it. Need to have exp working on all of these.
Interview Process:
- Two rounds of panel video interviews.
Job tags
Salary
