Duration: 12 Months
• Represents Regulatory Affairs on Post-Market RA Team for the Point-of-Care Business Area.
• Executes, manages and tracks all activities to support International Product Registrations to integrate newly acquired IVD medical devices for POC Business Area.
• Hosts recurring global communication activities (teleconferences etc.) with Country RA to ensure registration requirements are met.
• Interacts closely with multiple functions, including Manufacturing, R&D, Marketing, Logistics, Labeling etc.
• Completes the review of promotional material and device labeling for regulatory compliance.
- Minimum five years experience in Regulatory Affairs, preferably with a global manufacturer of medical devices.
- Experience with managing and preparing International Regulatory Submissions (CE Mark Technical Dossiers), other Global Submission 510(k)s, Pre-Submissions, and other regulatory submissions).
- Strong attention to detail with strong organizational and technical writing skills.
- Must manage multiple projects simultaneously.
- Must have experience working on multidisciplinary teams in a fast-paced, dynamic environment.
- Must have experience reviewing product labeling, including advertising/promotional materials.
- Must have strong written and verbal communication skills.
- Must be well versed in QSR Design Control requirements and in educating project teams on these requirements.
- BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification may be required in some areas