Sr. Regulatory Affairs Associate

GeneDx • New York City, NY

3d • $110,000 - $120,000 • Remote

About The Position

The Senior Regulatory Affairs Associate will play a key role in supporting GeneDx’s delivery of high-quality IVD products and services, ensuring compliance with applicable FDA and ISO requirements. The position requires working expertise in ISO 13485, ISO 14971, ISO 15189, and IEC 62304 for IVD medical devices. The Associate will collaborate cross-functionally with Development Lab, Product, Technology, Medical Affairs, and the Lab Director to support regulatory activities throughout the product lifecycle.

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.
• Ability to manage multiple projects and priorities in a fast-paced environment.

Nice To Haves

• Working experience in a clinical genetics laboratory is desired.
• Regulatory Affairs Professional Certification (RAC) preferred.

Responsibilities

• 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.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level