Job Description
Responsibilities
- Acts on behalf of Carestream Healthcare International Company Limited representing products in an assigned portfolio in assigned territory
- Work closely with the Regulatory Affairs team to establish and implement corporate regulatory policies and procedures to assure compliance with applicable international regulations and standards
- Work with internal regulatory resources, external distributors, and external consultants to obtain product registrations from in-country agencies
- Provide guidance on Product Safety and Quality System requirements to obtain marketing approval for products
- Assist in training on device regulations for medical devices
- Prepare dossiers for product registrations/approvals
- Maintain documentation system to assure all Carestream associates (regulatory, sales, marketing, etc.) have access to registration, license, permits, and etc. documents as required for registrations...