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Strong employer brand and metro location increase competition, but senior specialized regulated-role reduces it.
Regulated medical device and SaMD expertise required reduces cross-industry transferability.
Explicit 8+ years, regulated SaMD experience, and preferred certifications create strict shortlisting filters.
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Lead software quality initiatives across multiple product development programs, ensuring compliance with quality requirements, regulations, and industry standards throughout the Software Development Life Cycle (SDLC) and Product Development Process (PDP).
Provide oversight and technical leadership in software development, verification, validation, cybersecurity, risk management, and product release activities, including review and approval of key lifecycle deliverables.
Mentor engineers and cross-functional teams, drive continuous improvement in quality processes and risk-based decision making, and support audits and compliance efforts as a senior quality advisor.
8+ years experience in software quality engineering, software development, or related discipline within a regulated industry.
Working knowledge of IEC 62304, ISO 13485, FDA regulations, software risk management, and quality system requirements.
Bachelor’s degree in Computer Science, Software Engineering, Bioinformatics, Biomedical, or related discipline.
This role is not eligible for visa sponsorship. Occasional travel and willingness to work shifts supporting the US region are required.
Experienced in regulated software products including Software as a Medical Device (SaMD) and cloud-based/software-enabled systems.
Proven ability to influence multidisciplinary stakeholders and lead complex cross-functional initiatives without direct authority.
Skilled mentor and communicator able to promote software quality excellence and regulatory compliance across global product teams.