Regulatory Bioengineer

Regulatory & Clinical Affairs Engineers Location: San Diego, CA – Full-time (Hybrid) About the Role: We are seeking a motivated and committed Biomedical or Bioengineering professional to join our dynamic team in bringing an innovative medical device to market, who will report to the Chief Technology Officer and Director of Design Engineering. This role is critical to advancing our mission of bringing innovative vital signs monitoring and biomarker detection technology to patients and clinicians. As a Regulatory & Clinical Affairs Engineer, you will lead the FDA 510(k) regulatory clearance process for our InflammaSense Physiological Monitoring System (IPRS), taking ownership of submission preparation, clinical testing coordination, and quality system implementation. You will work closely with the engineering, clinical, and leadership teams to translate technical development into market-ready products. This position is ideal for a driven professional who is passionate about medical device development, thrives in a fast‑paced startup environment, and has the ability to balance strategic regulatory planning with hands‑on execution. You will have the opportunity to shape InflammaSense's regulatory foundation, influence the development of novel wearable monitoring technology, and play a pivotal role in delivering meaningful outcomes to patients. About InflammaSense InflammaSense is revolutionizing healthcare and clinical trials by integrating continuous, real‑time physiological monitoring (ECG, PPG, temperature, body motion) with Autonomic Neurography (ANG) and in‑silico analysis of saliva and blood biomarkers to provide objective, personalized insights into disease progression and treatment efficacy. This multimodal approach addresses critical gaps in detecting hemodynamic compromise and inflammatory conditions like sepsis, which currently cause 300,000 deaths annually due to slow diagnostics and imprecise treatments. By combining neural and molecular data with AI‑driven predictive modeling, the platform enables precision‑guided patient care, accelerates clinical trial efficiency through early responder identification, and offers competitive advantages through patented technology. Responsibilities Identify applicable FDA guidance documents and standards Prepare and coordinate 510(k) submission documents and supporting materials Develop and maintain technical documentation, including design history files, risk management files, and testing plans Draft clinical and non‑clinical testing plans aligned with regulatory requirements Implement testing according to protocol Work with clinicians to plan and execute clinical validation studies Collaborate with the engineering team for benchtop validation and verification Prepare test reports Stand up and implement the company’s Quality Management System Ensure compliance with FDA Quality System Regulations and applicable standards Prepare comprehensive test reports and analyze results for regulatory submissions Support post‑market regulatory activities Qualifications Bachelor’s or Master’s degree in Biomedical Engineering, Bioengineering, or Electrical Engineering with medical device experience Strong communication, technical writing, and documentation skills Detail‑oriented with excellent organizational abilities Ability to work independently and collaboratively Demonstrated track record as a high achiever with a strong drive for results Strong team player mindset Preferred Experience with vital sign monitoring or cardiovascular devices Familiarity with FDA medical device regulations and submission processes Knowledge of IEC 60601 and related medical device standards Prior experience with 510(k) submissions Experience with clinical study design or execution Pay and Benefits Pay Range: $60,000 - $80,000, depending on qualifications and experience. To Apply Please submit your resume and cover letter to Rahul Singh View email address on click.appcast.io. If you are eager to grow your career in medical device regulatory affairs and want to make a meaningful impact at an early‑stage company, we'd love to hear from you. In your cover letter, tell us why this role excites you and include your salary expectations. This position will remain open until filled. Applicants must be currently authorized to work in the United States on a full‑time basis. This company sponsors qualified applicants for work visas. #J-18808-Ljbffr InflammaSense