Regulatory Affairs Specialist (México)

Regulatory Affairs Specialist (México)

03 ago
|
Carestream
|
México

03 ago

Carestream

México

Carestream is an Equal Opportunity Employer

Carestream is an equal opportunity organization. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, gender identity, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Applying for a job with Carestream

All Carestream employees must complete the on-line application process. Carestream is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please click accommodations

Requisition ID: 4796

Position Summary:

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.
• 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, sales and marketing support.
• Monitor and communicat

📌 Regulatory Affairs Specialist (México)
🏢 Carestream
📍 México

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