Project Manager

Indotronix Avani Group; San Diego (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

Indotronix Avani Group seeks a Project Manager to lead cross-functional initiatives focused on regulatory readiness for in-market clinical diagnostic products. You will oversee dossiers, ensure compliance across development stages, and coordinate submissions with stakeholders.

The role requires a strong background in regulated environments, excellent communication, and the ability to balance competing priorities while maintaining quality systems and documentation controls.

Qualifications

• Bachelor’s degree in a scientific, engineering, regulatory, or related discipline.
• 3–5 years of project management experience in a regulated industry.
• Experience in medical devices, IVD, biotech, or life sciences environments.
• Proven ability to lead cross-functional initiatives with multiple stakeholders.
• Familiarity with product development docs, design controls, quality systems, and regulatory submissions.
• Experience coordinating complex documentation reviews and remediation activities.
• Familiarity with global regulatory frameworks for medical devices/IVD preferred.
• PMI PMP certification a plus but not required.

Responsibilities

• Lead cross-functional initiatives focusing on dossier audits and regulatory readiness for in-market clinical diagnostic products.
• Coordinate documentation reviews, compliance assessments, and remediation activities with stakeholders.

Skills

Project management

Cross-functional collaboration

Regulatory knowledge

Medical devices/IVD experience

Dossier audits

Regulatory submissions

Documentation & design controls

Education

Bachelor's degree in scientific/engineering/regulatory field

Job description

The Project Manager will lead cross-functional initiatives focused on technical dossier audits and regulatory readiness activities for in-market clinical diagnostic products

• Bachelor's degree in a scientific, engineering, regulatory, or related discipline.
• Minimum of 3-5 years of experience in project management within a regulated industry.
• Experience working in medical devices, in vitro diagnostics (IVD), biotechnology, life sciences, or related regulated environments.
• Demonstrated experience leading cross-functional initiatives involving multiple stakeholders and competing priorities.
• Working knowledge of product development documentation, design controls, quality systems, and regulatory submission processes.
• Experience coordinating complex projects involving documentation review, compliance assessments, or remediation activities preferred.
• Familiarity with global regulatory frameworks applicable to medical devices and IVD products is preferred.
• Experience supporting regulatory submissions, product registrations, or compliance programs is a plus.
• Project Management Professional (PMP) certification is a plus but not required.