Project Manager-Regulatory and compliance

About the Opportunity

LTIMindtree is a global technology consulting and digital solutions company that enables enterprises across industries to reimagine business models, accelerate innovation, and maximize growth by harnessing digital technologies. As a digital transformation partner to more than 750 clients, LTIMindtree brings extensive domain and technology expertise to help drive superior competitive differentiation, customer experiences, and business outcomes in a converging world. Powered by nearly 90,000 talented and entrepreneurial professionals across more than 30 countries, LTIMindtree — a Larsen & Toubro Group company — combines the industry-acclaimed strengths of erstwhile Larsen and Toubro Infotech and Mindtree in solving the most complex business challenges and delivering transformation at scale. For more information, please visit www.ltimindtree.com.

Responsibilities

• Maintain and improve the Quality Management System (QMS) in alignment with ISO 13485 and FDA regulations.
• Support digital transformation initiatives by integrating quality controls into automated and data-driven manufacturing processes.
• Ensure compliance with applicable regulatory requirements (FDA, EU MDR, ISO standards).
• Collaborate with cross-functional teams to embed quality assurance into digital workflows, MES (Manufacturing Execution Systems), and ERP systems.
• Monitor and validate data integrity across digital platforms used in production and quality control.
• Support implementation of predictive analytics and AI tools for quality monitoring and defect prevention.
• Lead or support IQ/OQ/PQ activities for new digital equipment and software systems.
• Review and approve validation protocols, technical documentation, and change controls.
• Maintain accurate and timely documentation of quality activities, including CAPAs, SCARs, and non-conformances.
• Prepare for and participate in internal audits (FDA, Notified Bodies).
• Conduct periodic reviews of trending analysis of quality metrics and digital system performance.
• Ensure audit readiness of digital systems and electronic records.
• Train staff on using tools, regulatory requirements, QMS procedures.
• Provide guidance on data governance, cybersecurity, and digital traceability in regulated environments.
• Experience in management of routers/Bill Of Materials (BOMs) and associated milestones in manufacturing paperwork/transition to a digital platform an advantage.
• Experience in DHR/DHR management/collaboration through use of electronic systems MES.
• Experience audit presenting on electronic DHR an advantage.
• Knowledge software validation electronic records compliance (21 CFR Part 11).

About You

A Senior-level FACTORY Business Project Manager will lead a cross-functional business team in launching new FACTORY supply chain and manufacturing IT systems.

Eligibility

Location: Athenry, Galway at Ireland
Hybrid – 2 days a week

Benefits

Not specified.

About Company

Not specified.