Post Market Clinical Quality

Are you passionate about improving patient outcomes through cutting-edge cardiac technologies?I'm partnering with a well-funded medical device company that recently received PMA approval for a breakthrough Class III CRT technology and is expanding its Clinical Quality and Post-Market Surveillance team. This is an opportunity to play a critical role in monitoring device performance, driving patient safety initiatives, and serving as a key clinical quality leader within a highly collaborative organization. What You'll Be DoingLead post-market surveillance and complaint handling activities for implantable cardiac devicesAssess device performance concerns, adverse events, and regulatory reportabilityServe as the clinical and technical quality SME across Quality, Regulatory, Clinical, R&D, and Manufacturing teamsSupport root cause investigations and identify emerging safety or performance trendsOwn and support FDA MDR submissions and global vigilance reportingHelp drive continuous improvement of post-market quality processes and patient safety initiatives What We're Looking For5+ years of Post-Market Surveillance, Complaint Handling, Clinical Quality, or Medical Device Quality experienceBS degree in Biomedical Engineering, Nursing, or related medical fieldActive RN or clinical licenseStrong background with Cardiac Rhythm Management (CRM), CRT, electrophysiology, pacemakers, ICDs, leadless pacing systems, or other implantable cardiac technologiesExperience evaluating clinical complaints, adverse events, and regulatory reporting requirementsDeep knowledge of FDA quality and post-market regulations within the medical device industry Why Consider This OpportunityFully remote flexibilityStrong compensation packageNewly approved, commercial-stage Class III technologyHigh visibility role with cross-functional leadership exposureOpportunity to directly impact patient safety and the future of cardiac resynchronization therapyApply Now for immediate consideration! EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change. To find out more about Real, please visit www.realstaffing.com