Regulatory & Quality Engineer

Regulatory & Quality Engineer at QRA Strategies LLC Regulatory & Quality Engineer at QRA Strategies LLC in San Leandro, California Posted in 3 days ago.

Type:

full-time

Job Description:

About the job Company Description QRA Strategies LLC helps early stage MedTech companies build their first Quality Management System and clear initial regulatory hurdles without slowing engineering. We treat compliance as an operational milestone. Startups often face limited engineering bandwidth and a compliance backlog that becomes technical debt. Mismanaged early, it burns capital and delays submissions. We close that gap with precise regulatory strategy and execution. Our team embeds with clients to build the operations required to manufacture devices while asking minimal time from core engineers. Our framework yields tangible results, demonstrated by recently securing a major foundational certification across four global markets for an early stage client. Role Description This is an on site Quality and Regulatory Engineer role based in the San Francisco Bay Area. Your objective is to drive execution on regulatory deliverables and quality system documentation. You will actively build and manage incoming inspection activities, equipment, risk management files, CAPAs, nonconformance investigations, and regulatory submissions. You will eliminate compliance bottlenecks by drafting controlled documents, executing action items, and organizing audit preparation materials. You will work directly with QA and RA strategists to ensure accurate record keeping and structured data management. This role requires hands on execution to commercialize medical devices and optimize the underlying economics of efficient regulatory pathways. Qualifications Proven experience with MedTech regulatory requirements, specifically FDA 510(k), CE Mark, ISO 13485, and EU MDR. Exceptional written communication skills for drafting technical documentation and summarizing clinical data. Highly organized with the proven ability to manage multiple complex workflows in a fast paced startup environment. Bachelor's degree or higher in biomedical engineering, life sciences, regulatory affairs, or a related discipline. Located in the San Francisco Bay Area and available for on site collaboration. Direct experience managing document control systems, building risk management files, and executing healthcare projects.