**Title:** Post-Market Surveillance Project Manager **Location:** 1820 McCarthy Blvd Milpitas, California USA 95035 **Duration:** 3 Months | 100% Onsite **Pay Range:** $75/ hr to $77/ hr (On W2) We are looking for a **“Post-Market Surveillance Project Manager** ” to join one of our Leading Healthcare Client. **Overview** We are seeking an experienced professional to support the integration of **post-market surveillance (PMS) procedures and processes** into an established quality management system. This role combines expertise in **post-market surveillance, regulatory compliance, and project management** to ensure product safety, compliance, and effective reporting. **Qualifications** + Minimum **6+ years of relevant experience** in medical devices, pharmaceuticals, biotech, or healthcare. + Bachelor’s degree in **Pharmaceutical, Chemical, Medical Technology, Biology, Engineering, or related field** required. + Master’s degree preferred. + Strong knowledge of **FDA regulations (21 CFR Part 820), ISO 13485, medical device reporting (MDR), and complaint handling** . **Key Responsibilities** **Post-Market Surveillance (PMS):** + Ensure PMS procedures align with **federal regulations (21 CFR Part 820)** . + Implement processes to evaluate complaints and adverse events, including MDR reporting. + Conduct trend analysis on complaints, product malfunctions, and customer dissatisfaction. **Project Management:** + Partner with business units, sponsors, and cross-functional teams to define project scope and deliverables. + Develop project plans, monitor initiatives, assign/guide staff, and track progress. + Provide regular updates, reports, and presentations to leadership. **Regulatory Compliance:** + Maintain compliance with **FDA, ISO 13485** , and other applicable regulations. + Support preparation and submission of **Medical Device Reports (MDRs)** . + Assist with regulatory audits and inspections. **Data Analysis & Reporting:** + Monitor product performance metrics and safety data. + Perform risk assessments and recommend corrective/preventive actions (CAPA). + Present findings to stakeholders and regulatory authorities. **Collaboration & Leadership:** + Work closely with **Quality, Regulatory, Clinical, and R&D teams** . + Mentor colleagues and foster accountability within PMS processes. **Soft Skills** + Strong **analytical thinking, attention to detail, and communication** skills. + Proactive problem-solving and adaptability in fast-changing regulatory environments. + Demonstrated **leadership, time management, and ethical judgment** . + Commitment to **patient safety and customer satisfaction** . **Interview Process** + **Round 1:** 45-minute phone screen. + **Round 2:** 1.5–2 hour in-person interview. **We are looking for the candidate who are eligible to work with any employers without sponsorship** . If you’re interested, please click **“Apply”** button. ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.