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, 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

Core Competencies

Demonstrates expertise in regulatory compliance for medical devices, including product registration processes and project management. Proficient in providing regulatory guidance and support across business units while ensuring adherence to international standards.

Certifications & Qualifications

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

Industry Keywords

• Medical Device
• Pharmaceutical
• Regulatory Policies
• International Regulations
• LATAM