stryker pm - Kasmo Global : Job Details

Rate: 55 Actalent, Don't post it as it is. Company Name: stryker inari (we have filled over 40 roles here so far..) Location: Irvine CA-onsite. Duration:2 years Title: mid level, they want someone 5-10 years ideally. Project Manager - Medical Devices (EU MDR Focus) Location: Irvine, CA Our client is seeking a dynamic and experienced Project Manager with a strong background in EU MDR compliance to join our team in Irvine, CA. In this role, you will lead cross-functional teams to deliver medical device projects that meet regulatory, quality, and business objectives-on time and within budget. Key Responsibilities:

• EU MDR Compliance Leadership: Ensure all projects align with EU MDR 2017/745 requirements, including technical documentation, risk management, clinical evaluation, and post-market surveillance (PMS).
• Resource Prioritization: Allocate and manage resources effectively to support EU MDR deliverables such as CERs, UDI implementation, and EUDAMED registration.
• Workflow & Performance Escalation: Identify and escalate workflow bottlenecks or performance issues that may impact regulatory timelines or product quality.
• Risk & Change Management: Lead risk assessments and change control processes in accordance with ISO 14971 and MDR expectations.
• Medical Device Expertise: Apply deep knowledge of the medical device lifecycle, including design controls, validation, and CE marking processes.

• Bachelor's degree in Engineering, Regulatory Affairs, Project Management, or a related field.
• Minimum 5 years of project management experience in the medical device industry, with at least 2 years focused on EU MDR transition or compliance.
• Strong understanding of ISO 13485, ISO 14971, and EU MDR 2017/745.