Job Description
📋 Description Lead global PMS programs aligned with regulatory requirements Ensure FDA reporting, eMDR, and vigilance processes Develop and improve quality/compliance audits across operations Manage audit planning, execution, tracking, and follow‑up Coordinate internal auditors and centralized audit records Monitor audit findings and implement corrective actions 🎯 Requirements Bachelor’s degree in a relevant field 4+ years in quality assurance, regulatory affairs, PMS, or related medical device functions Experience managing FDA reporting and compliance for medical devices Strong knowledge of medical device regulations, quality systems, audit processes Experience developing/managing PMS programs and regulatory reporting Experience leading teams in quality, compliance, or regulatory environments 🎁 Benefits Competitive annual salary range of $100,000 - $118,000 USD Fully remote work opportunity within the United States Comprehensive healthcare coverage including medical, dental, vision Employer‑paid life insurance and disability coverage 401(k) and HSA options Supplemental insurance programs including hospitalization and critical illness
