Job description Job description BIS Certification Executive is responsible for managing and overseeing the certification process under the Bureau of Indian Standards (BIS). Their role typically includes: Application Processing: Handling applications for BIS certification, ensuring all required documents are submitted. Compliance & Regulations: Ensuring products meet BIS standards and regulatory requirements. Coordination: Liaising with manufacturers, testing laboratories, and BIS officials. Audit & Inspection: Assisting in factory inspections and audits to verify compliance. Documentation: Maintaining records related to certification, renewals, and compliance reports. Technical Support: Providing guidance on BIS certification procedures and requirements Qualifications BE electronic, electrical or Mechanical. B Pharm Qualifications [Some qualifications you may want to include are Skills, Education, Experience, or Certifications.] Example: Excellent verbal and written communication skills Show more Show less

Job description BIS Certification Executive is responsible for managing and overseeing the certification process under the Bureau of Indian Standards (BIS). Their role typically includes: Application Processing: Handling applications for BIS certification, ensuring all required documents are submitted. Compliance & Regulations: Ensuring products meet BIS standards and regulatory requirements. Coordination: Liaising with manufacturers, testing laboratories, and BIS officials. Audit & Inspection: Assisting in factory inspections and audits to verify compliance. Documentation: Maintaining records related to certification, renewals, and compliance reports. Technical Support: Providing guidance on BIS certification procedures and requirements Qualifications BE electronic, electrical or Mechanical. B Pharm Experience: 0 to 2 years of experience. Job Location: Pimpri. Pune. Candidates preferable in nearby location. Industry Business Consulting and Services Employment Type Full-time Show more Show less

SaMD/SIMD Regulatory Affairs Executive Key Responsibilities: Prepare, compile, and submit regulatory documentation for SaMD/SIMD products, including 510(k), CE marking (under MDR), UKCA, and other global regulatory submissions. Ensure SaMD product development and maintenance align with relevant standards such as IEC 62304 , ISO 14971 , ISO 13485 , ISO 27001 , and applicable cybersecurity guidance. Maintain up-to-date knowledge of regulatory requirements and guidance related to SaMD (e.g., FDA’s premarket guidance, EU MDR Annex VIII, IMDRF SaMD framework). Provide regulatory input into product design and development documentation, including risk management, clinical evaluation, and labeling. Manage regulatory interactions with notified bodies and competent authorities. Support post-market surveillance, adverse event reporting, and regulatory compliance activities. Participate in audits and inspections. Monitor changes in global regulations and communicate impact to internal stakeholders. Qualifications: Education: Bachelor’s Biomedical Engineering, Information Technology, Computer Engineering or a related field. Experience: 1-4 years of experience in regulatory affairs, preferably with a focus on SaMD or Digital Health . Hands-on experience with regulatory submissions in key markets (FDA, EU, UK). Familiarity with software development lifecycle and documentation for regulated medical software. Experience working in a regulated environment (ISO 13485, QMS). Skills: Strong knowledge of global SaMD regulatory frameworks. Excellent written and verbal communication skills. Ability to interpret technical documentation and translate regulatory requirements clearly. Strong organizational and project management abilities. Preferred: Experience with Agile software development. Knowledge of AI/ML in SaMD and associated regulatory considerations. How to Apply : Send your CV on hr@operonstrategist.com or reach out via WhatsApp on 7822919196