SHS AT QT (Advanced Therapies Quality & Regulatory Team) is a global organization focused on ensuring product quality, regulatory compliance, and patient safety across the product lifecycle. It supports innovation by integrating Quality Engineering, Risk Management, Reliability Engineering, and regulatory expertise into product development. The team drives digitalization, AI adoption, and continuous process improvement to enhance efficiency and compliance.

SHS AT QT aims to deliver high-quality healthcare solutions faster, enabling better outcomes for patients, customers, and healthcare providers worldwide.

Responsibilities Analyzing, collecting data, and providing accurate, documented information about the status of quality

Verifying the correctness of quality related development results in compliance with the Quality Management Plan & authorize their release for medical devices

Validation of compliance to basic requirements, e.g. ISO standards and regulations like Medical Device Regulation (European Union Regulation), Quality system regulation (US FDA)

Assessment of completeness of Design history file and Device master records?

- Participate in reviews as per QMS, external and internal audits

Apply technical understanding of cybersecurity concepts to support project teams.

Identify gaps in existing cybersecurity processes and drive improvements.

Verify that cybersecurity deliverables are complete and compliant for product launches, regulatory submissions, audits,



and technical file updates Experienced in: Product risk management & non-product software validation processes for medical devices

Creation and maintenance of technical file/summary technical documentation (STED)

Medical device development (including SW) and Software engineering best practices

Agile methods / TIR45

Experienced in end-to-end (E2E) cybersecurity process handling across the product lifecycle

Reviews and interprets cybersecurity findings raised by various regulatory bodies and supports the related remediation activities

Supports the maintenance of post-market cybersecurity documentation to keep products audit-ready and prepared for regulatory review Knowledge: Implementing ISO 9001, 13485, ISO 14971, IEC 62304 & IEC 82304 within projects

Compliance of requirements from MDR, QSR

Non-regulated software like Apps for Apple / Android

Cybersecurity (ISO 80001, SW Vulnerability Management), Information security (ISO 27001)

Strong knowledge of product cybersecurity processes and valuable technical understanding of healthcare/medical device cybersecurity requirements

Knowledge of cybersecurity expectations from various regulatory bodies (FDA,EU & Korea etc), including FDA premarket & postmarket cybersecurity guidance, Knowledge of EU MDR requirements (MDCG 2019-16, Annex I security-related essential requirements), IEC 81001-5-1 (health software security), and IMDRF cybersecurity principles — at a process/regulatory-expectation level

📌 Project Quality Engineer- Cybersecurity Process Specialist (Bengaluru)
🏢 Siemens Healthineers
📍 Bengaluru