Merck KGaA
Regulatory Management Specialist
Job Description
You will lead regulatory compliance across key Indian frameworks (e.g., OTR, QCOs, BIS, DPIIT, MeitY, Ministry of Heavy Machinery), managing schemes like BIS CRS, CoC, and FMCS. As a thought leader, you’ll drive strategy, engage, BIS divisions, ministries for advocacy, and guide teams on regulation interpretation. Who you are:Minimum RequirementsBachelor’s /Master’s degree in Mechanical/Electrical Engineering or Material Science.Minimum of 6 years of experience in technical compliance, regulatory affairs, or product certification.Solid understanding of Indian standards, IEC standards and ISO standards, BIS regulations, and supply chain implications of technical regulations.Hands-on experience with BIS CRS, FMCS, CoC, Scheme X, Scheme 1.Proficiency in interpreting and applying Quality Control Orders under BIS Act.Preferred RequirementsExperience managing certification timelines and product registration/labelling processes.Familiarity with Omnibus Technical Regulation 2024 and its impact on heavy machinery/component manufacturers.Strong command over ISO 12100, IEC standards, and safety requirements.Demonstrated ability to conduct risk estimation, evaluation, and develop safety/compliance documentation.Skilled in policy research, regulatory comparison (e.g., WTO TBT agreements).Experience with government liaison (e.g., DPIIT, BIS, MHI) and industry associations (e.g., CII, FICCI).Strong written and verbal communication skills for stakeholder briefings, position papers, and policy documents.
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