Regulatory Affairs Specialist

**ZEISS in India** ZEISS in India is headquartered in Bengaluru and present in the fields of Industrial Quality Solutions, Research Microscopy Solutions, Medical Technology, Vision Care and Sports & Cine Optics. ZEISS India has 3 production facilities, R&D center, Global IT services and about 40 Sales & Service offices in almost all Tier I and Tier II cities in India. With 2200+ employees and continued investments over 25 years in India, ZEISS’ success story in India is continuing at a rapid pace.  Further information at [ZEISS India](https://www.zeiss.co.in/corporate/home.html). **Job purpose** To support the planning, execution, and management of regulatory activities for global medical devices (software and hardware), ensuring compliance with EU MDR, US FDA, and other country-specific regulations. The role focuses on preparing regulatory submissions, monitoring post-market commitments, and collaborating with cross-functional teams to meet program milestones. **Duties and responsibilities** **Regulatory Support:** * Assist in preparing technical documentation and submissions for Class I, IIa, and IIb medical devices in compliance with EU MDR and US FDA 510(k). * Support country-specific registration processes (e.g., China NMPA and other international markets). * Participate in the evaluation of regulatory impacts for design changes such as ECRs, PSM decisions, and updates to claims matrices. **Coordination and Collaboration:** * Collaborate with Product Management, Clinical Affairs, QA, and Program Delivery teams to align regulatory timelines with project objectives. * Represent Regulatory Affairs in team meetings and provide regulatory input to support product development and market approvals. **Submission and Documentation Management:** * Prepare and maintain documentation such as STED, GSPR, DoC, CER, and PMS reports. * Assist in monitoring timely country releases across various markets and manage change notifications. **Risk and Post-Market Oversight:** * Identify potential regulatory risks and propose mitigation strategies. * Support post-market regulatory activities, including responses to regulatory authorities and tracking post-market surveillance. **Process Improvement:** * Contribute to initiatives for process standardization and digitalization in regulatory activities (e.g., Signavio /CARA/Polarian /ADO tools). **Qualifications** * Bachelor’s/Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field. * 3–5 years of experience in Regulatory Affairs for medical devices. * Strong working knowledge of EU MDR and US FDA 510(k) requirements. * Exposure to multi-country registrations and clinical evaluation processes like CER and PMS is preferred. * RCC or equivalent certification is a plus. * Familiarity with technical documentation structure is an advantage. * Strong MS Office and documentation skills. **Other Attributes** * Strong attention to detail and structured problem-solving skills. * Effective communication and collaboration abilities in global cross-functional teams. * Accountability and ownership of assigned tasks. * Ability to adapt to evolving regulatory landscapes and manage ambiguity effectively * Comfortable working across time zones. **Job purpose** To support the planning, execution, and management of regulatory activities for global medical devices (software and hardware), ensuring compliance with EU MDR, US FDA, and other country-specific regulations. The role focuses on preparing regulatory submissions, monitoring post-market commitments, and collaborating with cross-functional teams to meet program milestones. **Duties and responsibilities** **Regulatory Support:** * Assist in preparing technical documentation and submissions for Class I, IIa, and IIb medical devices in compliance with EU MDR and US FDA 510(k). * Support country-specific registration processes (e.g., China NMPA and other international markets). * Participate in the evaluation of regulatory impacts for design changes such as ECRs, PSM decisions, and updates to claims matrices. **Coordination and Collaboration:** * Collaborate with Product Management, Clinical Affairs, QA, and Program Delivery teams to align regulatory timelines with project objectives. * Represent Regulatory Affairs in team meetings and provide regulatory input to support product development and market approvals. **Submission and Documentation Management:** * Prepare and maintain documentation such as STED, GSPR, DoC, CER, and PMS reports. * Assist in monitoring timely country releases across various markets and manage change notifications. **Risk and Post-Market Oversight:** * Identify potential regulatory risks and propose mitigation strategies. * Support post-market regulatory activities, including responses to regulatory authorities and tracking post-market surveillance. **Process Improvement:** * Contribute to initiatives for process standardization and digitalization in regulatory activities (e.g., Signavio /CARA/Polarian /ADO tools). **Qualifications** * Bachelor’s/Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field. * 3–5 years of experience in Regulatory Affairs for medical devices. * Strong working knowledge of EU MDR and US FDA 510(k) requirements. * Exposure to multi-country registrations and clinical evaluation processes like CER and PMS is preferred. * RCC or equivalent certification is a plus. * Familiarity with technical documentation structure is an advantage. * Strong MS Office and documentation skills. **Other Attributes** * Strong attention to detail and structured problem-solving skills. * Effective communication and collaboration abilities in global cross-functional teams. * Accountability and ownership of assigned tasks. * Ability to adapt to evolving regulatory landscapes and manage ambiguity effectively * Comfortable working across time zones. Your ZEISS Recruiting Team: Saptarshi Chowdhury