Regulatory Affairs Specialist
Regulatory Affairs Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Prepare and submit international regulatory submissions to support sales in key international markets. Interfacing with international country representatives Notified Bodies and Representative for registrations and significant changes to products
Release regulatory ship holds once approvals are obtained. Work with International Customer Service to resolve routine order ship holds for international shipments.
Maintain databases to ensure international regulatory requirements for new registrations as well as design changes are current and up to date.
Work with distributors and international partners to assess design process labeling changes to determine impact on existing registrations.
Submit CFG applications to FDA; FSC applications to State of CA FDB and international agencies as applicable
global labeling requirements in order to ensure compliant implementation post approval
Required Experience:
Unclear Seniority
Employment Type
Full-Time
