HeartFlow, Inc · 3 days ago

Regulatory Specialist

Austin, TX

Full-time

Remote

Entry Level

$90K/yr - $105K/yr

1+ years exp

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Responsibilities

Support frequent minor software releases by performing change assessments

Support EU MDR application and maintenance of technical documentation, including clinical evaluation

Collaborate with cross-functional teams to drive regulatory project management activities

Manage timely completion of new product registrations and maintain global regulatory approvals to market software devices

Collaborate with external partners including regulatory agencies, authorized representatives, importers, and distributors

Gain experience with US FDA submissions

Provide input to the risk management process to ensure risks are identified and updated during the product life-cycle

Conduct regulatory surveillance and communicate changes in regulations, standards, and guidances

Support Quality System management, as needed

Other relevant duties as assigned

Ability to work in a fast-paced adaptive environment, self-starter, and strong team player

Qualification

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Regulatory AffairsGlobal Regulatory RequirementsSoftware Medical DeviceChange AssessmentsEU MDRTechnical DocumentationClinical EvaluationProject ManagementNew Product RegistrationsFDA SubmissionsRisk ManagementRegulatory SurveillanceQuality System ManagementProblem-SolvingTeam PlayerAdaptabilityWordExcelPowerpointTeam collaborationCommunication