Clinical Risk Project Manager

Clinical Risk Project Manager

Our client, a leader in the medical device industry, is seeking a dedicated and experienced Clinical Risk Project Manager to join their dynamic team. As a vital part of the Clinical Affairs department, you will support cross-functional teams to ensure the safety and regulatory compliance of medical devices throughout their lifecycle. The ideal candidate will demonstrate strong analytical skills, excellent communication, and a collaborative spirit, aligning seamlessly with the organization's commitment to innovation and excellence.

Job Title: Clinical Risk Project Manager

Location: Santa Clara, CA, Sylmar, CA, Plano, TX, St. Paul, MN, or possibly remote (onsite visits required for equipment pickup and meetings)

Duration: 9+ months with highly possible extension/conversion

What's the Job?

• Lead and participate in clinical risk evaluation processes for medical device products.
• Create and maintain comprehensive Risk Evaluation Files (REFs) to document clinical risks and safety information.
• Facilitate Risk Alignment Committee (RAC) meetings, engaging cross-functional stakeholders to ensure alignment and informed decision-making.
• Interpret and evaluate clinical safety data from various sources, including investigations, post-market experiences, and scientific literature.
• Support global regulatory submissions and ensure ongoing communication with regulatory teams to address clinical risk disclosures.

What's Needed?

• Minimum of 5+ years of experience in healthcare, clinical research, medical writing, or related fields within the medical device or pharmaceutical industry.
• Previous experience working in the medical device industry with understanding of clinical research and regulatory guidelines.
• Strong analytical, critical thinking, and technical writing skills.
• Bachelor's Degree (advanced degrees in medicine, nursing, or biomedical sciences preferred).
• Ability to manage multiple projects efficiently in a fast-paced environment, with excellent communication skills.

What's in it for me?

• Opportunity to contribute to innovative medical device safety and compliance initiatives.
• Work with a collaborative and forward-thinking team dedicated to excellence.
• Potential for contract extension based on performance and project needs.
• Engage in meaningful work that impacts patient safety and healthcare outcomes.
• Flexible work arrangements with onsite and remote options to support work-life balance.