Regulatory & Quality Strategy Leader – Diagnostics

Initial Therapeutics, Inc.; North Brunswick Township (NJ); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Equity

Medical benefits

401k plan

Professional development

Impactful work

Leadership exposure

Collaborative environment

Job summary

Sonder Research X in North Brunswick, New Jersey, is seeking a Regulatory Affairs & Quality Lead to build and lead regulatory and quality capabilities. You will own scalable regulatory strategies and drive the Quality Management System across the organization to support clinical validation and future commercialization.

Collaborating with research, clinical development, manufacturing, AI, software, and leadership, you will translate evolving requirements into practical processes, ensuring

Qualifications

• Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, Quality, or related field.
• 5–8+ years of progressive Regulatory Affairs experience in regulated life sciences.
• Experience developing regulatory strategies and familiarity with FDA requirements.
• Hands-on experience with Quality Management Systems and CAPA, document control.
• Strong project management and cross-functional collaboration skills.
• Ability to work hands-on in a growth-stage biotech environment.

Responsibilities

• Develop and execute regulatory strategy and roadmap for clinical validation and commercialization.
• Assess regulatory pathways for LDTs, IVDs, and companion diagnostics.
• Lead regulatory planning for submissions and agency interactions.
• Monitor FDA and other requirements and translate into actionable guidance.
• Own and improve the QMS, SOP governance, training, CAPA, and change control.
• Coordinate internal audits and readiness for inspections.
• Integrate regulatory and quality requirements across R&D, lab ops, and manufacturing.
• Provide leadership across multidisciplinary programs and partnerships.
• Identify gaps and drive practical capability expansion.

Skills

Regulatory affairs

Quality management

Project management

FDA regulations

Cross-functional

Education

Bachelor's degree

Job description

Sonder Research X in North Brunswick, New Jersey, is seeking a Regulatory Affairs & Quality Lead to build and lead regulatory and quality capabilities. You will own scalable regulatory strategies and drive the Quality Management System across the organization to support clinical validation and future commercialization.

Collaborating with research, clinical development, manufacturing, AI, software, and leadership, you will translate evolving requirements into practical processes, ensuring