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Collabera · 12 hours ago

Regulatory Specialist II

South Portland, ME

Contract

Onsite

Mid Level

$30/hr - $40/hr

4+ years exp

Collabera is seeking a Regulatory Specialist II to support global regulatory activities for in vitro diagnostic medical devices. This role involves preparing and maintaining technical documentation for the European Union and supporting international product registrations while collaborating with product development and regulatory teams to ensure compliance with regulations.

ConsultingInformation ServicesInformation Technology

Hiring Manager

Nitya Galiara

Responsibilities

Prepare and author technical documentation in accordance with In Vitro Diagnostic Medical Device Regulation requirements

Provide regulatory support for diagnostic products in development and for commercially marketed products

Develop regulatory strategies to support product approvals, clearances, and modifications in the European Union and international markets

Support regional regulatory teams with submissions, renewals, and license amendments

Research and interpret scientific and regulatory information to support submission development

Compile, publish, and maintain submission dossiers, registrations, and marketing authorizations

Assess product, manufacturing, and labeling changes for regulatory impact and compliance

Develop internal regulatory procedures, tools, and guidance documents

Conduct informational and training sessions for cross-functional stakeholders

Maintain organized electronic and physical regulatory records in alignment with quality system requirements

Qualification

European Union regulationsVitro Diagnostic RegulationRegulatory submissionsQuality management systemsTechnical documentationWritten communicationVerbal communicationProject management