Business Consultant – MedTech QARA & Digital Transformation IRC288250

Description

About the Role

GlobalLogic is seeking a techno-functional Business Consultant with deep expertise in the MedTech domain. The ideal candidate will bridge the gap between Quality/Regulatory requirements and digital innovation.

You will play a pivotal role in modernizing Post-Market Surveillance (PMS) and CAPA processes by designing and implementing AI-driven automation solutions. You will act as the translator between Regulatory Subject Matter Experts (SMEs) and Data Science/Engineering teams to build compliant, efficient, next-generation quality systems.

 

Requirements

Must Have: MedTech Experience: Minimum 4+ years of experience working directly in the Medical Device or IVD industry.

Job responsibilities

Key Responsibilities
1. Domain Consulting (QARA Focus)
Process Analysis: Analyze existing Quality Management System (QMS) workflows, specifically focusing on Post-Market Surveillance (PMS), Complaint Handling, and Corrective and Preventive Action (CAPA).
Regulatory Compliance: Ensure all digital solutions align with global regulations, including EU MDR (2017/745), US FDA 21 CFR Part 820, and ISO 13485.
Risk Management: Assist in updating Risk Management Files (ISO 14971) based on insights derived from automated surveillance data.
Gap Assessment: Conduct gap analysis on legacy quality processes to identify inefficiencies that can be solved through digital intervention.
2. Technical Solutioning (AI & Automation)
Automation Strategy: Identify opportunities to deploy RPA (Robotic Process Automation) or scripting to automate manual data intake for complaints and adverse event reporting.
AI Implementation: Lead the functional design of Generative AI or NLP (Natural Language Processing) solutions to analyze unstructured data (e.g., patient feedback, clinical literature, service logs) for signal detection.
Prototyping: Provide hands-on assistance in creating Proof of Concepts (POCs) using low-code platforms or scripting (Python) to validate automation feasibility.
Data Translation: Define data labeling strategies and taxonomy to train ML models for categorization of complaints and root cause analysis.
3. Business Analysis & Stakeholder Management
Translate complex regulatory requirements into technical user stories and functional specifications for the engineering team.
Facilitate workshops with Quality Directors, Regulatory Leads, and Technical Architects.
Manage the product backlog for internal QARA digital tools.

Required Qualifications

Domain Expertise
MedTech Experience: Minimum 4+ years of experience working directly in the Medical Device or IVD industry.
QARA Knowledge: Strong understanding of Quality Assurance and Regulatory Affairs, with specific mastery of Post-Market Surveillance (PMS) and CAPA workflows.
Regulatory Standards: Deep familiarity with ISO 13485, EU MDR, and FDA Quality System Regulations (QSR).

Technical Skills (Hands-on)

AI/Data Proficiency: Practical experience with Data Analytics or AI/ML development lifecycles.
Tools: Proficiency in Python (for data analysis), SQL, or experience working with NLP libraries (e.g., for sentiment analysis or text classification in complaint logs).
Visualization: Ability to create dashboards using Tableau, PowerBI, or Spotfire to visualize Quality KPIs.
Soft Skills
Strong analytical and problem-solving mindset.
Ability to communicate technical concepts to non-technical regulatory stakeholders.
Agile/Scrum methodology experience.
Good to Have
Certification in RAPS (RAC) or ASQ (CQE/CQA).
Experience with eQMS platforms (e.g., TrackWise, Veeva Vault, MasterControl).
Experience implementing Generative AI (LLMs) for summarizing regulatory documents or clinical data.

What we offer

Culture of caring. At GlobalLogic, we prioritize a culture of caring. Across every region and department, at every level, we consistently put people first. From day one, you’ll experience an inclusive culture of acceptance and belonging, where you’ll have the chance to build meaningful connections with collaborative teammates, supportive managers, and compassionate leaders. 

Learning and development. We are committed to your continuous learning and development. You’ll learn and grow daily in an environment with many opportunities to try new things, sharpen your skills, and advance your career at GlobalLogic. With our Career Navigator tool as just one example, GlobalLogic offers a rich array of programs, training curricula, and hands-on opportunities to grow personally and professionally.

Interesting & meaningful work. GlobalLogic is known for engineering impact for and with clients around the world. As part of our team, you’ll have the chance to work on projects that matter. Each is a unique opportunity to engage your curiosity and creative problem-solving skills as you help clients reimagine what’s possible and bring new solutions to market. In the process, you’ll have the privilege of working on some of the most cutting-edge and impactful solutions shaping the world today.

Balance and flexibility. We believe in the importance of balance and flexibility. With many functional career areas, roles, and work arrangements, you can explore ways of achieving the perfect balance between your work and life. Your life extends beyond the office, and we always do our best to help you integrate and balance the best of work and life, having fun along the way!

High-trust organization. We are a high-trust organization where integrity is key. By joining GlobalLogic, you’re placing your trust in a safe, reliable, and ethical global company. Integrity and trust are a cornerstone of our value proposition to our employees and clients. You will find truthfulness, candor, and integrity in everything we do.

About GlobalLogic

GlobalLogic, a Hitachi Group Company, is a trusted digital engineering partner to the world’s largest and most forward-thinking companies. Since 2000, we’ve been at the forefront of the digital revolution – helping create some of the most innovative and widely used digital products and experiences. Today we continue to collaborate with clients in transforming businesses and redefining industries through intelligent products, platforms, and services.