Kasmo Global
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. Qualifications:
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 .
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. Qualifications:
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 .