Regulatory Affairs Specialist
VirtualVocationsDurham, North Carolina, United Statesjob_description.job_card.30_days_ago
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- serp_jobs.job_card.full_time
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A company is looking for a Regulatory Affairs - Design Control Specialist.
Key Responsibilities
Establish project-specific technical file deliverable lists aligning with internal SOPs and regulatory standards
Coordinate deliverables across teams and ensure compliance with design control expectations
Assist with international regulatory submissions and perform quality-related duties as assigned
Required Qualifications
5+ years of Quality Systems experience and Software as a Medical Device (SaMD) experience
3+ years in a project management or technical leadership role
Experience in a regulated agile development environment
Familiarity with global medical device regulations and standards
Demonstrated understanding of ISO 13485, ISO 14971, and IEC 62304
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Regulatory Specialist • Durham, North Carolina, United States
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