About the Role
Responsibilities:
Develop and execute regulatory strategies to support product submissions (, IDE, (k), De Novo) and post-market requirements.
Serve as the primary point of contact with the Food and Drug Administration (FDA) and their regulatory agencies, leading meetings, Q-Subs, and communications.
Collaborate with cross-functional teams (R&D, Clinical, QA, Manufacturing) to align regulatory strategies with product design, testing, and commercialization plans.
Prepare, review, and manage regulatory submissions, technical files, and design dossiers for and global markets.
Interpret and communicate regulatory requirements, guidance, and changes (, CFR Parts , , , ; ISO ; ISO ; MDR).
Ensure labelling, advertising, and promotional materials comply with FDA regulations and company policies.
Support quality and clinical teams in pre-submission meetings, audits, and inspections.
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