Hello,
Greetings for the day
This is
Basheer from
IntellecttINC. We have an opening for
Project Manager I role with one of our
Medical Device client located in
Santa Clara, CA. If you or anyone you know is interested in this opportunity, please feel free to reach me on
basheer@intellectt.com or you can call me at +1(732)-568-2674.
Role: Project Manager
Location: Santa Clara, CA – 95054
Duration: 12 Months
Shift Timing: 8 AM to 5 PM
100% Onsite Role
Job Summary
Manage and oversee regulatory compliance and product development projects for In Vitro Diagnostic (IVD) medical devices, ensuring compliance with FDA and IVDR standards. Responsible for project planning, execution, documentation, and cross-functional collaboration.
Key Skills
- Project Management
- Regulatory Compliance (FDA, IVDR)
- ISO 13485 experience
- Strong Organizational Skills
- Effective Communication
- Technical Documentation
- Experience with IVD Medical Devices
Qualifications
- 1-6 years of experience in project management, specifically within a regulatory environment.
- Experience with In Vitro Diagnostic (IVD) medical devices is preferred.
- Familiarity with FDA regulations, IVDR, and ISO 13485 standards.
- Strong organizational and communication skills.
- Proficiency in technical documentation and regulatory compliance processes.
Key Responsibilities
- Manage regulatory compliance and product development projects from inception to completion.
- Ensure projects adhere to FDA, IVDR, and ISO 13485 standards.
- Collaborate with cross-functional teams to define project scope and objectives.
- Maintain and update technical documentation, including regulatory filings.
- Provide regular project updates to management and key stakeholders.
- Support regulatory operations, including label reviews and state manufacturing license applications.