Design Engineer - Material Compliance

NovintiX; Hyderabad; On-site; INR 800,000 - 1,500,000; Full time

Job summary

NovintiX is seeking a seasoned material compliance professional to ensure regulatory conformity for medical devices and regulated industries. You will drive data accuracy across global frameworks and collaborate with R&D, QARA, and Supply Chain to close material gaps.

The role requires translating complex regulations into actionable requirements, maintaining documentation, and supporting multiple regions. A strong technical background in R&D engineering is preferred.

Qualifications

• 2 to 8 years of experience in material compliance and related roles in medical devices or regulated industries.
• Experience managing compliance with global materials regulations (REACH, RoHS, MDR, PFAS, TSCA, Prop 65, POP, CMR, ED).
• Experience performing material compliance gap assessments and driving closure with internal teams and suppliers.
• Experience responding to inquiries from internal, customer, and regulatory audiences regarding material data.
• Familiarity with ISO 13485 and MDR requirements; integrating material compliance into design controls and lifecycle management.
• Collaboration with R&D, QARA, Supply Chain, Procurement, and Suppliers.
• Data systems familiarity: BoM Check, Assent, iPoint, PLM/ERP modules.
• Experience supporting multiple regions in a global/international business environment.
• Strong technical background from R&D engineering disciplines.

Responsibilities

• Collaborate with R&D, QARA, and Supply Chain to maintain material compliance.
• Identify data gaps and drive closure with internal teams and suppliers.
• Respond to regulatory and customer inquiries regarding material data.
• Translate regulatory text into clear, actionable requirements.
• Prepare high-quality technical reports and compliance documentation.

Skills

Material compliance

Regulatory knowledge

MDR compliance

ISO 13485

Data management

Cross-functional teamwork

Risk assessment

Technical writing

Documentation

Regulatory reporting

Tools

BoM Check

Assent

iPoint

PLM/ERP modules

Job description

• 2 to 8 years of experience in Material Compliance, Product Stewardship, Regulatory material compliance, or related engineering roles within medical devices or other highly regulated industries.
• Hands-on experience managing compliance with global materials regulations, including but not limited to REACH, RoHS, MDR, PFAS, TSCA, Prop 65, POP, CMR, ED, and similar frameworks.
• Experience performing material compliance gap assessments, identifying missing or incomplete MoC/EPP data, and driving closure through internal teams and suppliers.
• Proven experience responding to internal, customer, and regulatory inquiries related to material compliance and environmental product data.
• Working knowledge of medical device quality and regulatory systems, including ISO 13485, MDR requirements, and integration of material compliance into design controls and lifecycle management.
• Experience collaborating cross-functionally with R&D, QARA, Supply Chain, Procurement, and Suppliers.
• Familiarity with material compliance data systems and tools (e.g., BoM Check, Assent, iPoint, PLM/ERP compliance modules) and managing large, complex datasets.
• Experience working in a global or international business environment, supporting multiple regions and stakeholders preferred.
• Strong technical background in R&D engineering disciplines.
• Excellent problem-solving, critical-thinking, and decision-making capabilities, with the ability to assess risk and recommend practical solutions.
• Strong technical reading and writing skills, with the ability to interpret regulatory text and translate it into clear, actionable requirements.
• Demonstrated ability to create high-quality technical reports, summaries, and compliance documentation for internal and external audiences.
• Ability to work under pressure, manage competing priorities, and meet tight deadlines with strong follow-through and accountability.
• Strong organizational and analytical skills, with high attention to detail and data accuracy.
• Ability to value diverse perspectives and experiences, and to establish trust and mutual respect when working with stakeholders across functions, cultures, and geographies.
• Effective communicator capable of engaging technical and non-technical audiences with clarity and confidence.
• Comfortable operating in matrixed, international teams and navigating ambiguity in evolving regulatory environments.
• Ability to work well in a team environment.