Regulatory Affairs Specialist

Role Overview

• 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

• 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

• Health insurance
• Retirement plans
• Paid time off
• Flexible work arrangements