Job Description
We are looking for an experienced and motivated Lead - QARA to oversee the software regulatory, compliance, and Software Development Life Cycle (SDLC) management of our IoT-based fertility tracking device for women. This role is critical in ensuring that our software meets international medical device regulations, particularly for SiMD (Software in a Medical Device) and MLMD (machine learning-enabled medical devices). The Lead will contribute significantly to the development process by ensuring that regulatory requirements are integrated into every phase of the product lifecycle, while also guiding a team of technical writers in producing high-quality documentation essential for compliance.
The Lead will play a key role in product development, ensuring the software adheres to important standards such as FDA, CE marking, ISO 13485, and IEC 62304.
Key Responsibilities
Regulatory and Compliance Oversight:
Ensure the software complies with global regulations related to medical devices (FDA, EU MDR, HIPAA, etc.).
Stay updated with FDA regulations, especially those relevant to MLMD (machine learning-enabled medical devices).
Collaborate with cross-functional teams (development, testing, legal) to ensure regulatory requirements are integrated into the SDLC.
Software Development Lifecycle (SDLC) Management
Lead the regulatory and compliance aspects of the SDLC for the fertility-tracking product line.
Ensure alignment with ISO 13485 (Quality Management Systems for Medical Devices), IEC 62304 (Software Lifecycle for Medical Devices), and ISO 14971 (Risk Management).
Develop and maintain processes for risk management, traceability, and testing during software development.
Oversee and sometimes contribute to the creation and maintenance of critical documentation like Software Requirements Specifications (SRS), Traceability Matrix, and Risk Analysis Matrix.
Technical Writing
Manage a team of technical writers responsible for generating detailed software documentation in compliance with regulatory standards.
Collaborate with software developers, testers, and regulatory bodies to ensure documentation is accurate and thorough.
Review and approve documents related to the SDLC, ensuring they meet quality and regulatory requirements.
Write and update technical documents (SRS, Traceability Matrix, Risk Analysis) to support the team.
Regulatory Audits & Submissions
Prepare the company for regulatory audits and ensure all documentation is audit-ready.
Liaise with regulatory bodies (FDA, EU, etc.) to ensure smooth submission processes for approvals and certifications.
Qualifications
Education: Bachelor's or Master's degree in Engineering, Software Development, Quality Assurance, or a related field.
Experience
8+ years of experience in quality assurance, regulatory compliance, or a similar role in the medical device or healthcare software industry.
Proven experience with FDA and EU MDR /EU IVDR regulations, especially for SiMD (Software in Medical Devices) and MLMD (machine learning-enabled medical devices).
Hands-on experience with EN ISO 13485, ISO 14971, and IEC 62304.
Technical writing experience related to medical devices and software compliance is essential.
Skills
Strong knowledge of global medical device regulations, including FDA QSR (21 CFR Part 820, 21 CFR 820.30,21 CFR Part 11(Optional) & 21 CFR Part 803), EU MDR/ EU IVDR, and other relevant standards.
Excellent understanding of machine learning in medical device software, particularly its regulatory implications.
Strong leadership and team management skills with experience overseeing technical writing teams.
Exceptional documentation and technical writing skills.
Strong attention to detail and the ability to manage multiple priorities.
Preferred Skills
Experience with software development methodologies (Agile, Waterfall etc) and tools (JIRA, Confluence).
Familiarity with risk management tools and methodologies used in medical device development.
Experience working with cross-functional teams, including hardware, software, and regulatory teams.
Experience in automating the processes and the relevant documentation.
