Project Manager
Fremont, CA · On-site
Project Manager - IVDR Technical Files & Label Cutover Location: Fremont, CA (Contract) Division: Clinical Diagnostics - Niche Diagnostics About the Role Join a pioneering leader in the diagnostics ...
Project Manager
Fremont, CA · On-site
Project Manager - IVDR Technical Files & Label Cutover Location: Fremont, CA (Contract) Division: Clinical Diagnostics - Niche Diagnostics About the Role Join a pioneering leader in the diagnostics ...
Facilitate cross-functional project meetings and track action items. * Manage the timeline for CE-IVDR and general supply chain. * Coordinate cross-functional activities required for inspection ...
Facilitate cross-functional project meetings and track action items. * Manage the timeline for CE-IVDR and general supply chain. * Coordinate cross-functional activities required for inspection ...
Facilitate cross-functional project meetings and track action items. * Manage the timeline for CE-IVDR and general supply chain. * Coordinate cross-functional activities required for inspection ...
Quick apply
Facilitate cross-functional project meetings and track action items. * Manage the timeline for CE-IVDR and general supply chain. * Coordinate cross-functional activities required for inspection ...
Facilitate cross-functional project meetings and track action items. * Manage the timeline for CE-IVDR and general supply chain. * Coordinate cross-functional activities required for inspection ...
Facilitate cross-functional project meetings and track action items. * Manage the timeline for CE-IVDR and general supply chain. * Coordinate cross-functional activities required for inspection ...
CE-IVDR Regulatory Consultant
Milpitas, CA · On-site +1
AccuScan Sciences is seeking an experienced CE-IVDR Regulatory Consultant to lead and support ... Strong project management and communication skills. Preferred * RAC certification and/or advanced ...
CE-IVDR Regulatory Consultant
Milpitas, CA · On-site +1
AccuScan Sciences is seeking an experienced CE-IVDR Regulatory Consultant to lead and support ... Strong project management and communication skills. Preferred * RAC certification and/or advanced ...
AccuScan Sciences is seeking an experienced CE-IVDR Regulatory Consultant to lead and support ... Strong project management and communication skills. Preferred * RAC certification and/or advanced ...
AccuScan Sciences is seeking an experienced CE-IVDR Regulatory Consultant to lead and support ... Strong project management and communication skills. Preferred * RAC certification and/or advanced ...
AccuScan Sciences is seeking an experienced CE-IVDR Regulatory Consultant to lead and support ... Strong project management and communication skills. Preferred * RAC certification and/or advanced ...
Quick apply
AccuScan Sciences is seeking an experienced CE-IVDR Regulatory Consultant to lead and support ... Strong project management and communication skills. Preferred * RAC certification and/or advanced ...
Scientific Project Manager (In Vitro Diagnostics)
Seattle, WA · On-site
$88K - $125K/yr
Support FDA and CE/IVDR regulatory submissions in collaboration with regulatory and quality teams ... Proficiency with project management tools (e.g., Microsoft Project). * Experience supporting FDA ...
Scientific Project Manager (In Vitro Diagnostics)
Seattle, WA · On-site
$88K - $125K/yr
Support FDA and CE/IVDR regulatory submissions in collaboration with regulatory and quality teams ... Proficiency with project management tools (e.g., Microsoft Project). * Experience supporting FDA ...
Scientific Project Manager (In Vitro Diagnostics)
Seattle, WA · Hybrid
$88K - $125K/yr
Support FDA and CE/IVDR regulatory submissions in collaboration with regulatory and quality teams ... Proficiency with project management tools (e.g., Microsoft Project). * Experience supporting FDA ...
Scientific Project Manager (In Vitro Diagnostics)
Seattle, WA · Hybrid
$88K - $125K/yr
Support FDA and CE/IVDR regulatory submissions in collaboration with regulatory and quality teams ... Proficiency with project management tools (e.g., Microsoft Project). * Experience supporting FDA ...
Scientific Project Manager (In Vitro Diagnostics)
Seattle, WA · On-site
$88K - $125K/yr
Support FDA and CE/IVDR regulatory submissions in collaboration with regulatory and quality teams ... Proficiency with project management tools (e.g., Microsoft Project). * Experience supporting FDA ...
Quick apply
Scientific Project Manager (In Vitro Diagnostics)
Seattle, WA · On-site
$88K - $125K/yr
Support FDA and CE/IVDR regulatory submissions in collaboration with regulatory and quality teams ... Proficiency with project management tools (e.g., Microsoft Project). * Experience supporting FDA ...
Clinical Project Manager- IVD
Durham, NC · On-site
$93K - $232K/yr
Knowledge of or experience with EU In Vitro Device Regulation (IVDR) submission process* Minimum of ... > 1 year's project management experience.* Conceptual and practical knowledge of Product ...
Clinical Project Manager- IVD
Durham, NC · On-site
$93K - $232K/yr
Knowledge of or experience with EU In Vitro Device Regulation (IVDR) submission process* Minimum of ... > 1 year's project management experience.* Conceptual and practical knowledge of Product ...
Be Seen First
Regulatory Affairs Associate - Medical Devices / IVDR
South Portland, ME · On-site
$20 - $23/hr
... project timelines and maintaining regulatory tracking and control systems. * Support the ... Participate in regulatory strategy, risk management, and other product lifecycle activities as ...
Quick apply
Be Seen First
Regulatory Affairs Associate - Medical Devices / IVDR
South Portland, ME · On-site
$20 - $23/hr
... project timelines and maintaining regulatory tracking and control systems. * Support the ... Participate in regulatory strategy, risk management, and other product lifecycle activities as ...
Clinical Project Manager- IVD
$93K - $232K/yr
Knowledge of or experience with EU In Vitro Device Regulation (IVDR) submission process * Minimum ... > 1 year's project management experience. * Conceptual and practical knowledge of Product ...
Clinical Project Manager- IVD
$93K - $232K/yr
Knowledge of or experience with EU In Vitro Device Regulation (IVDR) submission process * Minimum ... > 1 year's project management experience. * Conceptual and practical knowledge of Product ...
Clinical Project Manager- IVD
$93K - $232K/yr
Knowledge of or experience with EU In Vitro Device Regulation (IVDR) submission process * Minimum ... > 1 year's project management experience. * Conceptual and practical knowledge of Product ...
Clinical Project Manager- IVD
$93K - $232K/yr
Knowledge of or experience with EU In Vitro Device Regulation (IVDR) submission process * Minimum ... > 1 year's project management experience. * Conceptual and practical knowledge of Product ...
Clinical Project Manager- IVD
Durham, NC · On-site
$93K - $232K/yr
Knowledge of or experience with EU In Vitro Device Regulation (IVDR) submission process * Minimum ... > 1 year's project management experience. * Conceptual and practical knowledge of Product ...
Clinical Project Manager- IVD
Durham, NC · On-site
$93K - $232K/yr
Knowledge of or experience with EU In Vitro Device Regulation (IVDR) submission process * Minimum ... > 1 year's project management experience. * Conceptual and practical knowledge of Product ...
Reporting to the Global Director Clinical Affairs, the Senior Clinical Project Manager will be ... Generate clinical evaluation plans and reports for FDA and IVDR submissions. * Generate relevant ...
Reporting to the Global Director Clinical Affairs, the Senior Clinical Project Manager will be ... Generate clinical evaluation plans and reports for FDA and IVDR submissions. * Generate relevant ...
Reporting to the Global Director Clinical Affairs, the Senior Clinical Project Manager will be ... Generate clinical evaluation plans and reports for FDA and IVDR submissions. * Generate relevant ...
Reporting to the Global Director Clinical Affairs, the Senior Clinical Project Manager will be ... Generate clinical evaluation plans and reports for FDA and IVDR submissions. * Generate relevant ...
Senior Manager, Clinical Diagnostics CDx (Precision Medicine)
Tarrytown, NY · On-site
$150K - $245K/yr
Ensure compliance with ISO13485/14971, CLSI, IVDR, and GCP; maintain documentation, audit readiness, and proactive, integrated risk management. * Oversee design transfer, manufacturing readiness, and ...
Senior Manager, Clinical Diagnostics CDx (Precision Medicine)
Tarrytown, NY · On-site
$150K - $245K/yr
Ensure compliance with ISO13485/14971, CLSI, IVDR, and GCP; maintain documentation, audit readiness, and proactive, integrated risk management. * Oversee design transfer, manufacturing readiness, and ...
We are seeking a Senior Manager, Clinical Diagnostics to support end-to-end companion diagnostics ... Partner with IVD Regulatory on global submissions (FDA, EU IVDR, PMDA), supporting pre-subs ...
We are seeking a Senior Manager, Clinical Diagnostics to support end-to-end companion diagnostics ... Partner with IVD Regulatory on global submissions (FDA, EU IVDR, PMDA), supporting pre-subs ...
Ensure compliance with ISO 13485/14971, CLSI, IVDR, and GCP; maintain documentation, audit readiness, and proactive, integrated risk management. * Oversee design transfer, manufacturing readiness ...
Ensure compliance with ISO 13485/14971, CLSI, IVDR, and GCP; maintain documentation, audit readiness, and proactive, integrated risk management. * Oversee design transfer, manufacturing readiness ...
Project Manager Ivdr information
See salary details
$38.5K - $49.7K
2% of jobs
$49.7K - $61K
6% of jobs
$61K - $72.2K
10% of jobs
$78.3K is the 25th percentile. Wages below this are outliers.
$72.2K - $83.4K
13% of jobs
$83.4K - $94.6K
14% of jobs
The median wage is $98.6K / yr.
$94.6K - $105.9K
15% of jobs
$105.9K - $117.1K
13% of jobs
$119.6K is the 75th percentile. Wages above this are outliers.
$117.1K - $128.3K
12% of jobs
$128.3K - $139.5K
7% of jobs
$139.5K - $150.8K
5% of jobs
$150.8K - $162K
3% of jobs
$38.5K
$102.7K
$162K
How much do project manager ivdr jobs pay per year?
As of Sep 11, 2026, the average yearly pay for project manager ivdr in the United States is $102,682.00, according to ZipRecruiter salary data. Most workers in this role earn between $78,500.00 and $123,000.00 per year, depending on experience, location, and employer.
What cities are hiring for Project Manager Ivdr jobs?
Cities with the most Project Manager Ivdr job openings:
What are popular job titles related to Project Manager Ivdr jobs?
For Project Manager Ivdr jobs, the most frequently searched job titles are:
Project Manager
Fremont, CA • On-site
Indotronix International Corporation
• Recruiting and Staffing Services • 1 - 5K employees1,001 - 5,000 employees
Full-time
Medical, Life
This job post has expired 1 day ago. Applications are no longer accepted.
Job description
Project Manager - IVDR Technical Files & Label Cutover
Location: Fremont, CA (Contract)
Division: Clinical Diagnostics - Niche Diagnostics
About the Role
Join a pioneering leader in the diagnostics industry as a Project Manager driving critical IVDR Technical File assembly and Label Cutover initiatives. You will play a central role in ensuring regulatory compliance and the successful transition of product labeling across a diverse diagnostics portfolio. Collaborate with top-tier teams in Regulatory Affairs, Quality, R&D, Supply Chain, and Commercial Operations, contributing to impactful projects that shape the future of clinical diagnostics.
Responsibilities
- Lead end-to-end management of IVDR Technical File and labeling projects, from initiation through implementation
- Develop, track, and update comprehensive project plans, timelines, risk registers, and status reports
- Coordinate cross-functional teams to achieve deliverables on schedule and escalate issues as needed
- Facilitate project meetings and ensure timely execution of action items
- Support change management for product labeling and regulatory submissions
- Collaborate across Regulatory, Quality, Operations, Supply Chain, Manufacturing, and Marketing to align project goals
- Maintain accurate project documentation in accordance with quality and regulatory standards
- Track readiness, inventory, and cutover milestones for successful product transition
- Identify and mitigate risks impacting regulatory timelines or market continuity
Required Skills and Experience
- Bachelor's degree in Life Sciences, Engineering, Business, Regulatory Affairs, or related field
- 3-5 years' experience in project management, coordination, regulatory, quality, or operations within a regulated industry (medical device, diagnostics, healthcare)
- Proven track record managing cross-functional projects with multiple stakeholders
- Strong organizational and communication skills with attention to detail
- Proficiency in Smartsheet, Excel, PowerPoint, and collaboration tools
- Ability to manage multiple priorities in a dynamic environment
- Effective facilitator with a proactive, collaborative mindset
Preferred Skills
- Exposure to IVDR or regulated product environments
- Experience with regulatory compliance, labeling changes, or technical documentation projects
- Knowledge of medical device or diagnostic regulatory requirements
Benefits
- Opportunity to make a significant impact in a globally recognized diagnostics division
- Professional growth through collaboration with industry leaders and exposure to cutting-edge regulatory projects
- Supportive, innovative, and cross-functional team environment
- Flexible contract role with potential for extension
How to Apply
Ready to advance your career in diagnostics project management? Submit your application and join a team dedicated to excellence, innovation, and compliance.
Location: Fremont, CA (Contract)
Division: Clinical Diagnostics - Niche Diagnostics
About the Role
Join a pioneering leader in the diagnostics industry as a Project Manager driving critical IVDR Technical File assembly and Label Cutover initiatives. You will play a central role in ensuring regulatory compliance and the successful transition of product labeling across a diverse diagnostics portfolio. Collaborate with top-tier teams in Regulatory Affairs, Quality, R&D, Supply Chain, and Commercial Operations, contributing to impactful projects that shape the future of clinical diagnostics.
Responsibilities
- Lead end-to-end management of IVDR Technical File and labeling projects, from initiation through implementation
- Develop, track, and update comprehensive project plans, timelines, risk registers, and status reports
- Coordinate cross-functional teams to achieve deliverables on schedule and escalate issues as needed
- Facilitate project meetings and ensure timely execution of action items
- Support change management for product labeling and regulatory submissions
- Collaborate across Regulatory, Quality, Operations, Supply Chain, Manufacturing, and Marketing to align project goals
- Maintain accurate project documentation in accordance with quality and regulatory standards
- Track readiness, inventory, and cutover milestones for successful product transition
- Identify and mitigate risks impacting regulatory timelines or market continuity
Required Skills and Experience
- Bachelor's degree in Life Sciences, Engineering, Business, Regulatory Affairs, or related field
- 3-5 years' experience in project management, coordination, regulatory, quality, or operations within a regulated industry (medical device, diagnostics, healthcare)
- Proven track record managing cross-functional projects with multiple stakeholders
- Strong organizational and communication skills with attention to detail
- Proficiency in Smartsheet, Excel, PowerPoint, and collaboration tools
- Ability to manage multiple priorities in a dynamic environment
- Effective facilitator with a proactive, collaborative mindset
Preferred Skills
- Exposure to IVDR or regulated product environments
- Experience with regulatory compliance, labeling changes, or technical documentation projects
- Knowledge of medical device or diagnostic regulatory requirements
Benefits
- Opportunity to make a significant impact in a globally recognized diagnostics division
- Professional growth through collaboration with industry leaders and exposure to cutting-edge regulatory projects
- Supportive, innovative, and cross-functional team environment
- Flexible contract role with potential for extension
How to Apply
Ready to advance your career in diagnostics project management? Submit your application and join a team dedicated to excellence, innovation, and compliance.
About Indotronix
Sourced by ZipRecruiter
In 1986, Indotronix established itself in the staffing space. 22 years later, Avani entered the scene, offering consulting and technology development. Finally, in 2016, the two joined forces to begin delivering talent across all areas, from Staffing to Consulting to unique platform development.
Industry
Recruiting and staffing services
Company size
1,001 - 5,000 Employees
Headquarters location
Rochester, NY, US