Product Manager - IVD
We are proud to be working with a leading certification body in the USA, renowned for its excellence in compliance, quality, and regulatory standards within the medical device industry. As part of our continued growth, we are actively seeking experienced IVD professionals to join their expert team.
Role Overview:
We are looking for professionals with a strong background in In Vitro Diagnostics (IVD) who have 5+ years of experience in a medical device Notified Body or regulatory environment. This is an exciting opportunity to contribute to maintaining the highest standards of safety, performance, and quality in IVD products globally.
Key Responsibilities:
Conduct audits and technical reviews of IVD devices in accordance with applicable regulations and standards (e.g., ISO 13485, IVDR, FDA 21 CFR Part 820).
Evaluate technical documentation, risk management files, clinical evidence, and performance data.
Support certification processes and ensure timely compliance with regulatory frameworks.
Collaborate with internal teams and external clients to deliver expert guidance on IVD-related regulatory matters.
Requirements:
Minimum of 5 years' experience in the IVD industry, preferably within a Notified Body or similar regulatory organization.
In-depth knowledge of IVD regulations (e.g., EU IVDR, FDA regulations).
Experience in auditing or reviewing IVD technical documentation.
Strong communication, analytical, and organizational skills.
Advanced degree in life sciences, biotechnology, medical technology, or related field preferred.
Why Join?
Be part of a globally respected certification body.
Work with industry-leading professionals in a dynamic and impactful role.
Competitive compensation and career growth opportunities.
Flexible, remote-friendly working environment.