We are looking for Clinical Risk Evaluation Project Manager for our client in Santa Clara, CA

Job Title: Clinical Risk Evaluation Project Manager

Job Location: Santa Clara, CA

Job Type: Contract

Job Overview:

Pay Range: $52.14hr - $57.14hr

Provide cross-functional support to ensure clinical safety and residual risk information is aligned across product documentation throughout the product lifecycle.
Support compliance with quality management systems and regulatory submission requirements.
Manage clinical risk documentation and ensure consistency across all related materials.
Work in a fast-paced environment handling multiple projects and timelines.

Experience:

5+ years of experience in healthcare, clinical research, medical writing, or related fields within the medical device or pharmaceutical industry.

Responsibilities:

Write and manage product master files related to clinical risks, adverse events, and safety information.
Lead and participate in the clinical risk evaluation process across the product lifecycle.
Create and maintain Risk Evaluation Files for medical device products.
Lead Risk Alignment Committee meetings and collaborate with cross-functional stakeholders.
Facilitate and document decision-making processes with proper rationale.
Identify, interpret, and evaluate clinical safety data from various sources including clinical studies, post-market data, and scientific literature.
Review and ensure alignment of clinical risk information across documents such as Instructions for Use, clinical reports, and safety updates.
Support global regulatory submissions and maintain communication with regulatory stakeholders.
Assist in responding to regulatory authorities, ethics committees, and review boards.
Maintain knowledge of assigned products and therapeutic areas.
Support continuous process improvement initiatives.
Ensure compliance with corporate policies, procedures, and regulatory guidelines.

Skills:

Qualification And Education:

Clinical Risk Evaluation Project Manager

Key skills