QA/RA Project Manager

This position is posted by Jobgether on behalf of DeepHealth. We are currently looking for a QA/RA Project Manager in South Carolina. This role is ideal for a detail-oriented and strategic professional who thrives at the intersection of quality assurance, regulatory compliance, and project management. The QA/RA Project Manager will oversee quality and regulatory activities across the product development lifecycle, ensuring medical device software and digital health solutions meet the highest standards of safety, performance, and compliance. The position requires cross-functional collaboration with R&D, regulatory, clinical, and operations teams. You will lead QARA workstreams, manage risks and issues, implement continuous improvement initiatives, and provide clear reporting to executive stakeholders. This is a hands-on position where your work directly impacts product quality, regulatory readiness, and operational excellence. Accountabilities ·         Lead quality assurance and regulatory integration across design controls, risk management, verification/validation, and design transfer phases. ·         Partner with Regulatory Affairs to support audits, gap assessments, and regulatory submissions (FDA 510(k), CE Mark, etc.). ·         Manage defect analysis, root cause investigations, and CAPA implementation to ensure resolution and closure. ·         Champion continuous improvement initiatives using Lean Six Sigma methods to enhance product reliability and compliance workflows. ·         Identify, assess, and mitigate risks related to product quality, safety, and regulatory timelines. ·         Serve as the QARA lead for product development initiatives, ensuring alignment with phase-gate milestones. ·         Facilitate cross-functional coordination between engineering, clinical, regulatory, and QA teams to resolve blockers and meet program targets. ·         Provide timely reporting on quality status, risks, and dependencies to the PMO and executive stakeholders. Requirements ·         5+ years of program/project management experience in SaaS, health tech, or similarly regulated industries. ·         Strong knowledge of healthcare quality and regulatory standards: ISO 13485, FDA 21 CFR Part 11/820, IEC 62304, EU MDR. ·         Proficiency in quality tools and methodologies: FMEA, CAPA, root cause analysis, SPC, Six Sigma. ·         Skilled in project management with experience leading complex, multi-disciplinary projects. ·         Proficiency in tools like SmartSheet, Jira, or Ketryx preferred. ·         Familiarity with clinical environments, patient safety best practices, and medical device or remote patient monitoring systems. ·         Excellent communication, stakeholder management, and cross-functional collaboration skills. ·         Ability to lead without direct authority, drive outcomes, and manage risk effectively. ·         Detail-oriented, high accountability, problem-solving mindset. ·         Bachelor’s degree required; Microsoft Office proficiency essential. Benefits ·         Competitive salary: $85,000 - $95,000 per year. ·         Fully remote role with minimal travel (~10%). ·         Opportunity to work on innovative digital health and medical device projects. ·         Hands-on leadership role with cross-functional exposure and impact. ·         Professional growth and development in a regulated, fast-evolving industry. Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching. When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly. 🔍 Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience, and achievements. 📊 It compares your profile to the job’s core requirements and past success factors to determine your match score. 🎯 Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role. 🧠 When necessary, our human team may perform an additional manual review to ensure no strong profile is missed. The process is transparent, skills-based, and free of bias — focusing solely on your fit for the role. Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps, such as interviews or additional assessments, are made by their internal hiring team. Thank you for your interest!   #LI-CL1