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Collabera · 17 hours ago

Regulatory Affairs Specialist-Entry Level

Scarborough, ME

Contract

Onsite

Mid Level

$30/hr - $38/hr

4+ years exp

Collabera is seeking a Regulatory Affairs Specialist II to support regulatory activities for diagnostic products, focusing on European Union and international markets. This role involves preparing regulatory documentation, supporting product development, and ensuring compliance with regulatory requirements.

ConsultingInformation ServicesInformation Technology

Hiring Manager

Gagandeep Singh

Responsibilities

Prepare and maintain regulatory documentation in accordance with In Vitro Diagnostic medical device regulations

Provide regulatory support for product development and commercial diagnostic products

Develop regulatory strategies for new and modified products to support approvals in the European Union and international markets

Support regional regulatory teams with submissions, renewals, and amendments

Research and interpret scientific and regulatory information to support submission documentation

Compile, publish, and maintain materials required for submissions, renewals, and annual registrations

Maintain existing approvals, licenses, and authorizations

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

Develop and maintain internal regulatory procedures and tools

Conduct informational or training sessions for internal stakeholders

Organize and maintain electronic and hard copy regulatory files

Support compliance with quality system requirements and applicable regulatory standards

Demonstrate professional conduct in interactions with internal and external partners

Qualification

Regulatory AffairsVitro Diagnostic regulationsBachelor’s degreeProficiency with WordProficiency with ExcelProficiency with PowerPointProficiency with VisioCommunication skillsManaging prioritiesTeamworkIndependent work