Mozarc Medical · 5 hours ago

Senior Regulatory Specialist (New England area or Remote)

Rhode Island, United States

Full-time

Remote

Mid, Senior Level

$90K/yr - $151K/yr

4+ years exp

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Hiring Manager

Rekha Roveri

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Responsibilities

Develop and execute global regulatory strategies for new and existing medical devices to ensure compliance with FDA, EU MDR, and other global regulatory requirements

Assess product and process changes, serving as regulatory point of contact on large-scale projects

Manage both devices and kits, ensuring product complies with all global regulations

Assist in the review of product labeling, ensuring compliance with materials of concern and international standards

Review and approve advertising and promotional materials to ensure regulatory compliance

Collaborate with cross-functional teams, including R&D, Quality, and Marketing, to provide regulatory guidance and support throughout the product lifecycle

Interact with regulatory authorities and notified bodies

Assist in the development and maintenance of internal regulatory policies and procedures

Qualification

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FDA regulationsEU MDRRegulatory submissionsTechnical filesExcel masterySmartsheetsNotary PublicWindchill