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 I