Risk Manager • Senior

Who you are

You have extensive experience in risk management, particularly in the medical device industry, and a strong understanding of post-market surveillance processes. Your background includes evaluating and improving risk management programs to ensure compliance with applicable regulations and standards. You are a subject matter expert in data-driven safety analytics and have a proven track record of maintaining ISO 14971-compliant risk management practices. You thrive in collaborative environments and are skilled at communicating complex concepts to cross-functional teams.

You possess strong analytical skills and are adept at assessing and analyzing risk factors associated with product design and quality systems. Your ability to document and recommend remediation and improvement activities is key to your success in this role. You are detail-oriented and have a passion for ensuring the safety and efficacy of medical devices.

What you'll do

In this role, you will drive post-commercialization risk management efforts and lead data-driven safety analytics initiatives. You will serve as a key resource for evaluating risk management programs and ensuring alignment with regulatory requirements. Your responsibilities will include planning, documentation, and recommending improvement activities across product design and quality systems. You will collaborate with various teams to enhance risk management processes and contribute to total product life cycle efforts.

You will be responsible for maintaining compliance with ISO 14971 and other relevant standards, ensuring that risk management practices are effectively integrated into the company's quality system. Your expertise will guide the organization in making informed decisions regarding product safety and risk mitigation strategies. You will also play a crucial role in training and mentoring team members on best practices in risk management and post-market surveillance.

What we offer

At NeuroPace, we value our employees as our greatest asset and strive to create a dynamic and challenging work environment. We offer competitive compensation and benefits packages, along with opportunities for professional growth and development. You will be part of a dedicated team focused on transforming the lives of people suffering from epilepsy through innovative medical technology. Join us in making a meaningful impact in the healthcare industry.