Regulatory Affairs Specialist

About This Role

Supporting the planning, execution, and management of regulatory activities for global medical devices, including both software and hardware, is the main focus of this role. The specialist ensures compliance with EU MDR, US FDA, and other country-specific regulations, preparing submissions and monitoring post-market commitments while collaborating with cross-functional teams to meet program milestones.

Responsibilities

• 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
• 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
• 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
• Identify potential regulatory risks and propose mitigation strategies
• Support post-market regulatory activities, including responses to regulatory authorities and tracking post-market surveillance
• Contribute to initiatives for process standardization and digitalization in regulatory activities (e.g., Signavio /CARA/Polarian /ADO tools)

Requirements

• 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
• 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
• Strong MS Office and documentation skills

Nice to have:

• Exposure to multi-country registrations and clinical evaluation processes like CER and PMS
• RCC or equivalent certification
• Familiarity with technical documentation structure

About the Company

ZEISS in India is headquartered in Bengaluru and operates in the fields of Industrial Quality Solutions, Research Microscopy Solutions, Medical Technology, Vision Care, and Sports Cine Optics. The company has 3 production facilities, an R&D center, Global IT services, and about 40 Sales Service offices across almost all Tier I and Tier II cities in India, with over 2200 employees and continued investments over 25 years.