Job Title:
Project Manager (Regulatory & Compliance) - (Medical, Pharma)
Location:
Santa Clara, CA - 95054
Duration: 12 Months
Location: 100% Onsite
Experience Level: 1-6 years
Shift Timings: 8 am to 5 pm
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.
Best Regards,
Kiran Kumar Oddupalli
+1 73239 86563
kiran.o@intellectt.com