Regulatory Affairs Associate

Position Title Regulatory Affairs Associate Location Santa Clara, CA Contract Duration 12 months, 100% onsite Summary We are seeking a Regulatory Affairs & Quality Specialist with experience in medical devices and international regulations. The role involves handling regulatory submissions, interpreting letters from multiple countries, supporting cross‑functional teams, and ensuring compliance with quality and documentation standards. Key Responsibilities Manage regulatory submissions, approvals, and letters across multiple countries Interpret regulatory letters and ensure proper actions are taken Support document control, change orders, and quality system procedures Navigate international regulatory requirements and support multiple franchises Provide critical thinking and problem‑solving for regulatory and quality issues Maintain trackers, documentation repositories, and ensure compliance with standards Qualifications Background in Regulatory Affairs and Quality for medical devices Experience with international regulatory processes and approvals Strong critical thinking and problem‑solving skillsAbility to handle document control, change orders, and franchise support Strong organizational skills and ability to work independently Benefits Medical and Prescription Drug Plans Dental Plan Vision Plan Health Savings Account (for High‑Deductible Health Plans) Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit) Supplemental Life Insurance Short Term Disability (coverage varies by state) Long Term Disability Critical Illness, Hospital coverage, Accident Insurance MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance 401(k) #J-18808-Ljbffr