Regulatory Affairs Specialist

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...