Regulatory Affairs, Labeling, Medical Devices, Consultant

Regulatory Affairs, Labeling, Medical Devices, Consultant

Summary

Our client, a global medical device company, has engaged GForce Life Sciences to identify a regulatory affairs consultant with experience in domestic (FDA) and international (EU) regulatory settings to join their team to assist in their labeling regulatory affairs efforts.

Duties / Expectations of Role

• Organizes regulatory information, tracks, and controls submissions.
• Reviews marketing materials and labeling and advices on labeling for compliance with regulatory filings for Class I- III medical devices.
• Reviews product changes for impact on regulatory filing worldwide.
• Participates as part of a team ensuring regulatory compliance and contributes to department and cross-department project meetings.
• Provide regulatory guidance to colleagues to confirm subsequent documentation will meet the needs of the regulatory submissions.
• Help prepare US 510(k)s, Letters to File
• Responsible for the preparation of International Registration Dossiers for product registration and license renewals in global
• Assist with maintaining and updating CE Technical Files per MDR (as required).
• Present regulatory status in team meetings, effectively interacting with New Product Commercialization, R&D, Quality, and Manufacturing to meet project deadlines.
• Manage communication to support international government agencies concerning inquiries or requests for additional information and coordinate efforts across the company
• Maintain regulatory files/database. Establish and maintain a system for tracking changes in documents submitted to agencies or distributors.
• Review labeling and labels for compliance with regulatory requirements.

Mandatory Requirements

• Bachelor's Degree in life sciences, technical/engineering or related field
• 5+ years of experience working in a regulated industry; medical device experience is preferred
• Understanding of FDA and ISO medical device regulations, including 510k submissions
• Strong in business software such as Excel, Word, PowerPoint, and Outlook.

Nice to Have Requirements

• 1-3 years of experience in orthopedic, spine, or medical device industry
• Regulatory Affairs Certification preferred (US or EU)
• Global Experience
• International culture awareness and foreign language skills
• Understanding of CE Technical Files and International Registration Dossiers
• Experience with implementation and maintenance of Unique Device Identification labeling projects

Term & Start

• ASAP
• 10-12+ month contract
• Onsite in Northern, OH
• Full time (40hrs/week) - Benefits included: health, dental, vision, 401k