Regulatory Affairs Specialist

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.
• Aid 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.

Required Skills & Education

• 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.
• Duties should have included responsibility at least one program area and the exercise of independent judgment in the performance of assigned duties.
• Experience interacting with Health Authorities is a must
• Fully fluent in English and Spanish
• 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
• Carestream is an Equal Opportunity Employer