Sr. Regulatory Manager

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 Senior Regulatory Affairs Manager will play a critical role in ensuring 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. The position requires working expertise in FDA IVD requirements, ISO (13485, 14971, 15189, etc.), CLIA and New York State CLEP requirements. This position will collaborate extensively with Operations, Product & Technology, Commercial, Medical Affairs and other teams to develop and execute plans to support the GeneDx’s product and services.

MAJOR DUTIES AND REPONSIBILITIES

• Lead the implementation of quality and regulatory strategies to ensure compliance with FDA, ISO, and other regulations.
• Provide regulatory and quality guidance during design and development process, risk management, change management, process validation/controls, and equipment qualification.
• Work closely with Operations, Product & Technology, Commercial, Medical Affairs and other teams to ensure applicable quality & regulatory requirements affecting these teams are defined and implemented.
• Monitor and interpret changes to quality and regulatory requirements and provide guidance to GeneDx cross-functional teams.
• Prepare and submit regulatory submissions to relevant authorities.
• Support regulatory inspections and audits, ensuring successful outcomes.
• Provide mentorship, regulatory and quality training to internal teams or cross-functional peers and on maintaining compliance with the applicable QMS requirements and regulations.
• Identify and drive continuous improvements initiatives that enhance quality culture within the organization.
• Additional duties maybe assigned.

COMPETENCIES

• Ability to work independently and as part of a cross-functional team.
• Ability to lead projects involving cross-functional teams
• Strong project management and organizational skills.
• Excellent communication and interpersonal skills.
• Detail-oriented with strong analytical and problem-solving abilities.

QUALIFICATIONS / EDUCATION

• A bachelor’s or advanced degree in a relevant field scientific or technical field (e.g., Biology, Chemistry, Engineering).
• Certifications in Regulatory Affairs or Quality Assurance preferred.

TECHNICAL REQUIREMENTS

• Experience working with software as a medical device (SaMD) regulation is preferred.
• 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.
• Excellent technical writing skills.

EXPERIENCE

• Minimum of 7 years of experience in quality and regulatory affairs within the medical device or IVD industry.
• Working experience in a clinical genetics laboratory is desired.
• Practical experience with FDA, ISO 13485, ISO 14971 and ISO 15189 regulations.

CERTIFICATES, LICENSES, REGISTRATIONS

• 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.