Job Description
Responsibilities:
• Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy for US and International submissions.
• Timely compilation of materials for license renewals, updates, and registrations
• Participate in the research of regulatory issues and dissemination of regulatory information to Production, QA, QC, and R&D departments and senior management as required.
• Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process.
• Complete submissions to FDA, and EU regulatory entities
• Review advertising and marketing material for appropriateness and compliance with regulatory requirements and laws
• Manage SOPs and work instructions relative to regulatory responsibilities.
Requirements:
• Working knowledge of FDA regulations associated with operating a high-quality manufacturing environment.
• Excellent organizational and interpersonal skills, including the ability to successfully work with internal and external customers.
• Solid track record at attaining FDA 510k clearances, DeNovo, or PMA approvals preferably with reagent based IVD devices.
• Familiar with attaining the CE mark under IVDD and the upcoming IVDR requirements.
• Strong analytical skills and excellent communication and presentation skills (both written and verbal).
• Ability to work effectively in a fast-paced, deadline-oriented environment.
• Bachelor's Degree (master's preferred) and 7-10 years in a GMP environment , In Vitro Diagnostic (IVD), Pharmaceutical, Life Science, Biotech, or Medical Device experience preferred.
Position Type: Contract
PayRate: $0-$0 per hour