Senior Regulatory Affairs Associate

November 10

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GeneDx

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At GeneDx, we believe that everyone deserves personalized, targeted medical care—and that it all begins with a genetic diagnosis. Fueled by one of the world’s largest rare disease data sets, our industry-leading exome and genome tests translate complex genomic data into clinical answers that unlock personalized health plans, accelerate drug discovery, and improve health system efficiencies. It all starts with a single test.

1001 - 5000 employees

📋 Description

• Support the development and execution of regulatory strategies to ensure FDA authorization and global compliance for IVD and Software as a Medical Device (SaMD) products. • Prepare and contribute to regulatory submissions, including FDA pre-submissions, 510(k), De Novo, and EU IVDR Technical Documentation. • Collaborate with cross-functional teams to ensure regulatory requirements are integrated throughout the product lifecycle. • Provide regulatory input during design and development activities, including risk management, change control, verification/validation, and labeling. • Monitor and interpret evolving regulatory requirements and standards (e.g., ISO 13485, ISO 14971, IEC 62304, IEC 62366) and assess impact on product development and compliance. • Support internal audits and regulatory inspections, including preparation of documentation and development of CAPAs related to regulatory findings. • Deliver regulatory training and guidance to internal teams to support ongoing compliance and foster a strong quality and regulatory culture. • Contribute to continuous improvement initiatives within the Regulatory Affairs function.

🎯 Requirements

• A bachelor’s or advanced degree in a relevant scientific or technical field (e.g., Biology, Chemistry, Engineering). • Minimum of 5 years of experience in regulatory affairs within the medical device or IVD industry. • Practical experience with FDA authorization and EU IVDR submissions, design controls, ISO 13485, ISO 14971, IEC 62304 and ISO 15189 regulations. • Experience with Software as a Medical Device or medical devices containing software. • Working experience in a clinical genetics laboratory is desired. • Ability to manage multiple projects and priorities in a fast-paced environment.

🏖️ Benefits

• Paid Time Off (PTO) • Health, Dental, Vision and Life insurance • 401k Retirement Savings Plan • Employee Discounts • Voluntary benefits