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.

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