Daniel Biank

Vice President Regulatory & Government Affairs @Accuray

Madison, WI, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jul 2020 — Present

Vice President Regulatory & Government Affairs @Accuray

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Madison, WI, US

Global head of Regulatory & Government Affairs representing Accuray to global regulators and lawmakers. Drive patient access and innovation by leading advocacy to policymakers, trade associations and regulators; providing external intelligence, premarket product strategy and processes to support international distribution. Lead regulatory and quality for regional sales and service businesses as well as oversee the Global Audit program and manage Accuray’s Notified Body and authorized representative relationships.

EDUCATION

2005 — 2010

University of Wisconsin-Madison

Doctor of Law (J.D.)

2002 — 2004

University of Illinois Chicago

Master of Engineering (MEng), Engineering

1997 — 2001

Valparaiso University

Bachelor of Science (BS), Electrical Engineering (BSEE)

SKILLS

GmpQuality SystemV&VQuality AssuranceValidationIso 13485Iec 60601Medical DevicesClinical ResearchProduct DevelopmentManagementHealthcareDesign ControlRegulatory SubmissionsProgram ManagementChange ControlLeadershipProduct Launch21 Cfr Part 11Clinical TrialsMdlProcess ImprovementR&DU.s. Food and Drug Administration (Fda)Regulatory RequirementsMedical ImagingMriBiomedical EngineeringCe MarkingContinuous Improvement21 CfrCross-Functional Team LeadershipIso 14971Regulatory AffairsBusiness Process ImprovementFdaHealthcare ReimbursementRisk Management

ABOUT DANIEL BIANK

Strategic medical product executive with deep legal and regulatory expertise and 25+ years successfully commercializing innovations for global markets. I partner across industry, government, and academia to accelerate patient access to advanced healthcare technologies, while building and leading high performing teams. With a proven track record across US, EU, Japan, and China, I deliver results through disciplined risk management, integrated quality systems and scalable global market strategies.

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