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Starkey Hearing · 2 days ago

Sr Regulatory Affairs Specialist I

Eden Prairie, MN

Full-time

Hybrid

Senior Level, Lead/Staff

$89K/yr - $126K/yr

8+ years exp

Starkey Hearing is a world leader in the manufacturing and distribution of advanced hearing technologies. The Sr. Regulatory Affairs Specialist I position is responsible for supporting the Regulatory Affairs Department for all medical devices and hearing-related products, ensuring compliance with regulations and maintaining technical files.

Health CareMedical DeviceWellness

Hiring Manager

Kelly Sheppard

Responsibilities

Ensure market access of our products World-Wide

Support assessments and completion of documentation for submission filings to comply with regulatory requirements

Support labeling compliance before product release

Support coordination of Homologation device delivery, testing & registration within new markets

Help to Compile, prepare, review and submit regulatory submission to authorities

Provide regulatory input to product lifecycle planning

Maintain records to comply with regulatory requirements

Support wireless requirements compliance throughout the product development process

Participate in Product Risk management within product development (per project) and work with others to mitigate

Ensure product safety issues and product-associated events are reported to regulatory agencies

Participate in risk-benefit analysis for regulatory compliance

Support senior personnel in periodical scan of changes in standards, regulations, guidance and events in the areas of Medical Devices, Radio Devices, Noise Protection Devices, and Environmental

Some participation in professional associations, industry/trade groups and appropriate standards organizations

Other duties/responsibilities as assigned

Qualification

GxPsISO 13485Quality Management SystemsEU MDR21CFR820Strategic PlanningWritten communicationVerbal communicationPresentation skillsCritical thinkingAttention to detail