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.

The Regulatory Affairs Associate will support GeneDx teams to initiate and maintain regulatory & quality documentation. The role will also support other regulatory and quality activities to ensure that GeneDx continues to deliver high-quality products and services to our customers while maintaining compliance to applicable FDA, CLIA, CAP, NY, and ISO requirements.

MAJOR DUTIES AND REPONSIBILITIES

• Initiate the preparation of regulatory and quality documentation as needed.
• Assess design, production, process changes or modifications to applicable regulatory requirements.
• Author, revise, review, and approve standard operating procedures and work instructions.
• Conduct research on regulatory and quality requirements and guidelines.  
• Assist in the preparation and submission of regulatory filings to relevant health authorities. 
• Maintain and organize regulatory & quality system documentation and databases. 
• Support the regulatory team in responding to inquiries from regulatory agencies. 
• Review and approve labeling, marketing materials, and promotional content for regulatory compliance. 
• Participate in cross-functional team meetings to provide regulatory support. 
• Monitor for changes in regulatory requirements and assist in assessing their impact on GeneDx's products and processes. 
• Support the development and maintenance of quality management systems. 
• Support continuous improvements initiatives that enhance quality culture within the organization
• Assess design changes and production and process changes regulatory requirements.
• Additional duties maybe assigned.

COMPETENCIES

• Ability to work independently and as part of a cross-functional team.
• Strong organizational skills.
• Excellent communication and interpersonal skills.
• Detail-oriented with problem-solving abilities.

QUALIFICATIONS / EDUCATION

• Minimum bachelor’s degree in a relevant scientific or technical field (e.g., Biology, Chemistry, or Biomedical Engineering).

TECHNICAL REQUIREMENTS

• Working knowledge of FDA, CLIA, CAP, NY, and ISO 13485, ISO 14971, ISO 15189 requirements.
• Knowledge of design and development with software used as a medical device (SaMD) or software used as component in a medical devices / IVDs and applicable regulations.
• Good technical writing skills.

EXPERIENCE

• Minimum 1-3 years of experience in a regulatory affairs role within the medical device or diagnostics industry.

CERTIFICATES, LICENSES, REGISTRATIONS

• Post Graduate Regulatory Affairs Certificate or Diploma preferred.
• Regulatory Affairs Professional Certification (RAC) preferred.

PHYSICAL DEMANDS

• Ability to stand, walk, and sit for extended periods.

WORK ENVIRONMENT

• Work is primarily performed in an office setting with a typical climate-controlled environment or remote in-home setting.
• Standard work hours are Monday through Friday, 9 AM to 5 PM EST