Regulatory Affairs Specialist

Acts on behalf of Carestream Healthcare International Company Limited representing products in an assigned portfolio in assigned territory and works with BU Sales Managers. Works with country Health Authorities, regulators and/or trade associations to assure accurate compliance interpretations are obtained, and to influence decisions where appropriate.

Position Responsibilities

• 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.
• Maintain documentation system to a...