Regulatory Affairs Specialist

Carestream

Regulatory Affairs Specialist managing compliance and product registrations for Carestream Healthcare. Collaborating with Sales and Regulatory Affairs teams to establish corporate policies and documentation.

Posted 7/9/2026full-timeZapopan • 🇲🇽 MexicoMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

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, sales and marketing support
Monitor and communicate changes to medical device products laws, standards, guidance, etc.
Manage external services such as agencies and product test houses
Submit dossiers and provide Regulatory Affairs (RA) support/coordination for product registrations/approvals and ensure registrations in line with business time and cost requirements
Strongly support product registration in assigned region
Answer questions and enquires from distributors, dealers and customers for regulatory evidence requests
Cooperate with Sales and Service; share of information on important customer/process issues
Supply regulatory expertise to sales managers to help support effective business plans

Requirements

What you’ll need

Bachelor degree in a business, science, engineering or health related field (or other relevant discipline)
A minimum of 5 years directly relevant experience in a medical device or pharmaceutical company
Experience interacting with Health Authorities is a must
Fluent English and Spanish is a must
Leadership in driving Internal and external registration processes and projects
Experience in LATAM regulatory registration requirements
Have an understanding of technical products (ie. Software, Hardware, Radiology)
Project management skills and communication
Ability to provide accurate advice to all levels within the company
Knowledge of repositories and IT competence
Excellent interpersonal skills and strong virtual communication skills
Must have sense of urgency, must be able to recognize and set priorities
Close teamwork to Regulatory Affairs, Sales and Service across business units

Benefits

Comp & perks

Health insurance
Retirement plans
Paid time off
Flexible work arrangements

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Regulatory AffairsProduct SafetyQuality System RequirementsDossier PreparationMedical Device RegulationsTechnical Product UnderstandingHealth Authority InteractionDocumentation ManagementRegulatory Evidence RequestsIT Competence

Soft Skills

Interpersonal SkillsVirtual Communication SkillsSense of UrgencyPrioritizationTeamwork

Certifications

Bachelor Degree in Business, Science, Engineering or Health Related Field