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Principal Medical Safety Specialist - CRMDx

Nalu Medical

Arden Hills, MNJobPosted 3 days agoStill listed 2 days ago

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At a glance

Compensation
No compensation found
Location
Arden Hills, MN
Work Authorization
Not specified

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Requirements

Credentials this posting asks for.

Bachelor's degree

Job overview

Nalu Medical seeks a Principal Medical Safety Specialist for CRMDx. The role calls for a healthcare or life sciences degree, active clinical licensure, and substantial patient-care experience, including cardiology or electrophysiology and medical safety or related device work. The candidate should bring expertise in cardiac rhythm management technologies, safety and risk processes, medical-device regulations, and regulated quality systems.

Skills & qualifications

RequiredNice to have

Skills

Clinical JudgmentAnalytical SkillsIndependent Decision-MakingAmbiguity ManagementPriority ManagementLeadershipTechnical WritingVerbal CommunicationCross-Functional CollaborationInfluenceClinical SupportCIED Implant ProceduresCardiac Rhythm ManagementPacemakersImplantable Cardioverter-DefibrillatorsCardiac Resynchronization TherapyS-ICD SystemsLeadless Pacing SystemsCardiac Monitoring SystemsDevice InterrogationDevice TroubleshootingSafety Signal EvaluationRisk ManagementPost-Market SurveillanceQuality InvestigationsBenefit-Risk AssessmentsMedical Device RegulationsMedical Device Quality SystemsMultidisciplinary Collaboration

Qualifications

Bachelor's in Healthcare, Life Sciences or Related FieldActive RN, APRN/NP or PA Licensure5+ Years Direct Patient Care Experience2+ Years Cardiology or Electrophysiology ExperienceRecent Field-Based Clinical Experience2+ Years Medical Safety, Clinical Research, Clinical Quality or Related Device Experience

Full job description

Bachelor's degree in health care, life sciences or a related field Active professional licensure as a registered nurse (RN), advanced practice registered nurse/nurse practitioner (APRN/NP), or physician assistant (PA) Minimum of five (5) years of experience in direct patient care, including a minimum of two (2) years of experience in cardiology and/or electrophysiology with advanced CIED interrogation and troubleshooting experience Strong clinical judgment and analytical skills, with the ability to interpret complex medical, scientific and product performance information Demonstrated ability to make sound independent decisions, navigate ambiguity, manage competing priorities and lead complex work with minimal supervision Excellent technical writing and verbal communication skills, with the ability to clearly communicate complex clinical and safety information Demonstrated ability to build effective cross-functional relationships and influence without formal authority Recent experience in a field-based clinical role providing clinical and technical support for CIED implant procedures Advanced experience with cardiac rhythm management (CRM) technologies, including pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy (CRT) devices, subcutaneous implantable cardioverter-defibrillator (S-ICD) systems, leadless pacing systems, cardiac monitoring systems, and device interrogation and troubleshooting Minimum of 2 years of experience in Medical Safety, Clinical Research, Clinical Quality, or a related medical device function Experience with safety signal evaluation, risk management, post-market surveillance, quality investigations, and/or benefit-risk assessments Working knowledge of global medical device regulations and requirements Experience working within a regulated medical device quality system and across multidisciplinary teams

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