Medical Device RA/QA Specialist

We are looking for a detail-oriented QA/RA professional to support ongoing quality system, regulatory, and manufacturing-readiness activities across multiple device programs. This is a flexible remote role for someone comfortable working in a fast-moving startup environment and jumping into a mix of documentation, compliance, supplier-quality, and regulatory support work as needed. The ideal candidate has hands-on experience with FDA-regulated medical devices and is comfortable helping organize and move projects forward without needing a lot of oversight. Responsibilities may include: * Assisting with QMS documentation and quality system organization * Supporting design control and DHF document management * Reviewing supplier/manufacturer documentation and quality records * Assisting with FDA registration/listing activities * Supporting technical documentation organization and gap assessments * Helping prepare or review SOPs, templates, and controlled documents * Supporting verification/validation documentation tracking * Assisting with manufacturing-readiness and supplier-quality activities * Participating in internal project meetings and follow-up tracking * Helping organize submission-related documentation and evidence packages * General QA/RA administrative and operational support as needed Preferred Experience: * Medical device QA/RA experience (FDA regulated products required) * Familiarity with 21 CFR 820 / QMS requirements * Experience with design controls and DHF structure * Experience working with contract manufacturers or suppliers * Familiarity with FDA submissions, technical files, or regulatory documentation * Strong organizational and communication skills * Able to work independently and manage multiple priorities Nice to Have: * ISO 13485 familiarity * Experience with airway, endoscopy, surgical, or Class I/II devices * Startup or early-stage company experience * Experience helping clean up or organize existing quality systems/documentation Engagement Details: * Part-time / flexible hours * Remote * Workload will vary week to week depending on project phase and timelines * Looking for someone reliable who can become a long-term support resource as programs progress