Regulatory Affairs Specialist

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.