QA / RA Manager

Location: On-site, Modi’in

Employment Type: full time, on site.

About Us:

At Dosentrx, we’re transforming how oral drug therapies are delivered and monitored. Our innovative technology is already impacting lives — with patient adoption growing 500% year over year. We’re expanding fast, and looking for talented, detail-oriented people who thrive on responsibility and quality.

The Role:

We are seeking a hands-on QA/RA Manager to lead quality and regulatory activities for a Class II, software-integrated medical device. The role includes ownership of the QMS (ISO 13485), FDA QMSR readiness (21 CFR 820), supplier quality, audit readiness, cross-functional compliance support, and support for pre-sub and 510(k) submission.

Responsibilities

· Maintain and improve the QMS (ISO 13485) and ensure FDA QMSR compliance (21 CFR 820).

· Lead design controls and design reviews, DHF/DMR management, CAPA, complaints, document and change control, and related quality system processes.

· Establish, implement, and maintain core SOPs for the QMS, including production and process controls, ECOs, training, internal audits, and supplier qualification.

· Manage risk management (ISO 14971) and IEC 62304 software lifecycle processes.

· Lead V&V planning and approval for hardware and software.

· Support preparation of the 510(k) submission and pre-sub interactions with the FDA, working closely with regulatory consultants.

· Oversee manufacturing validation, audits, and training programs.

· Manage supplier quality, including qualification, quality agreements, incoming inspection (IQC/OQC), vendor audits, and MRB processes.

· Collaborate with Product, Engineering, and Operations to ensure compliance throughout development.

Requirements

· B.Sc. in Biomedical Engineering, or a related engineering field.

· 5+ years of QA/RA experience in the medical device industry, including strong 510(k) experience.

· Deep knowledge of ISO 13485, 21 CFR 820, ISO 14971, and IEC 62304.

· Proven experience with design controls, design reviews, CAPA, risk management, and supplier quality processes.

· Strong communication skills (English & Hebrew).

· High integrity, strong interpersonal communication skills, and a proactive, solution-oriented approach.

· Comfortable working hands-on in a fast-paced startup environment.