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
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.
Work Environment
- This is a fully remote position. The employee will work from a home office or other suitable remote location with reliable high-speed internet access. Work is performed in a climate-controlled environment using standard office equipment including computer, phone, and video conferencing tools. Your standard work schedule and hours will be established in collaboration with your leader and may be adjusted to align with evolving business needs.
Physical Demands
This is a sedentary role requiring prolonged periods of sitting while working at a computer. Physical demands include:
- Sitting for extended periods (up to 8 hours per day)
- Repetitive use of hands and fingers for typing and mouse operation
- Visual acuity for reading computer screens and documents
- Ability to communicate effectively via phone and video calls
- Occasional lifting of up to 10 pounds (office supplies, equipment)
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
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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Science - Minded, Patient - Focused.
At GeneDx, we create, follow, and are informed by cutting-edge science. With over 20 years of expertise in diagnosing rare disorders and diseases, and pioneering work in the identification of new disease-causing genes, our commitment to genetic disease detection, discovery, and diagnosis is based on sound science and is focused on enhancing patient care.
Experts in what matters most.
With hundreds of genetic counselors, MD/PhD scientists, and clinical and molecular genomics specialists on staff, we are the industry’s genetic testing experts and proud of it. We share the same goal as healthcare providers, patients, and families: to provide clear, accurate, and meaningful answers we all can trust.
SEQUENCING HAS THE POWER TO SOLVE DIAGNOSTIC CHALLENGES.
From sequencing to reporting and beyond, our technical and clinical experts are providing guidance every step of the way:
TECHNICAL EXPERTISE
- High-quality testing: Our laboratory is CLIA certified and CAP accredited and most of our tests are also New York State approved.
- Advanced detection: By interrogating genes for complex variants, we can identify the underlying causes of conditions that may otherwise be missed.
CLINICAL EXPERTISE
- Thorough analysis: We classify variants according to our custom adaptation of the most recent guidelines. We then leverage our rich internal database for additional interpretation evidence.
- Customized care: Our experts review all test results and write reports in a clear, concise, and personalized way. We also include information for research studies in specific clinical situations.
- Impactful discovery: Our researchers continue working to find answers even after testing is complete. Through both internal research efforts and global collaborations, we have identified and published hundreds of new disease-gene relationships and developed novel tools for genomic data analysis. These efforts ultimately deliver more diagnostic findings to individuals.
Learn more About Us here.
Our Culture
At GeneDx, we are dedicated to cultivating an environment where creativity and innovation thrive. We believe in the power of community and collaboration, where diverse perspectives are embraced, and every voice contributes to our shared success. Our team is a vibrant mix of professionals who challenge and support each other in equal measure, fostering growth both personally and professionally. When you join us, you're not just taking on a job—you're joining a movement. A movement that champions curiosity, embraces change, and believes in making an impact, one patient at a time. Cultural principles we live by:
- Be bold in our vision & brave in our execution.
- Communicate directly, with empathy.
- Do what we say we're going to do.
- Be adaptable to change.
- Operate with a bias for action.
Benefits include:
- Paid Time Off (PTO)
- Health, Dental, Vision and Life insurance
- 401k Retirement Savings Plan
- Employee Discounts
- Voluntary benefits
GeneDx is an Equal Opportunity Employer.
All privacy policy information can be found here.
