Sr. Regulatory Affairs Associate

GeneDx (Nasdaq: WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation services, fueled by the world’s largest, rare disease data sets. For more information, please visit www.genedx.com.

 Summary 

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.

 Job 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.

 People Manager

• No

 Education, Experience, and Skills

• 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.

Certificates, Licenses, Registrations

• Regulatory Affairs Professional Certification (RAC) preferred.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• • Ability to sit for extended periods.

Work Environment

• Work is primarily performed in a remote office setting.

Acknowledgements

The above job description is not intended to be an all-inclusive list of duties and standards of the position.  Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.   

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