01 Oct
|
NovintiX
|
Hyderabad
01 Oct
NovintiX
Hyderabad
- 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 transparent, 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 ac
📌 Design Engineer (Hyderabad)
🏢 NovintiX
📍 Hyderabad