PHARMAFull-time
Regulatory Affairs Specialist
BANGALORE (IN)ONSITEPOSTED: 7/23/2026
PHARMAFull-time
HIRING ORGANIZATIONZEISS INDIATechnology
ROLE DEFINITION & RESPONSIBILITIES
ZEISS India is inviting applications for the position of Regulatory Affairs Specialist in Bangalore, Karnataka. This is an excellent opportunity for experienced Regulatory Affairs professionals with expertise in medical devices, EU MDR, US FDA 510(k), technical documentation, and global regulatory submissions. The role involves supporting regulatory strategies for software and hardware medical devices while collaborating with cross-functional global teams.
Key Responsibilities
Prepare regulatory submissions for Class I, IIa, and IIb medical devices.
Support compliance with EU MDR and US FDA 510(k) regulations.
Assist country-specific registrations including NMPA and global markets.
Prepare technical documentation including STED, GSPR, DoC, CER, and PMS reports.
Evaluate regulatory impact of design changes and product updates.
Coordinate with Product Management, Clinical Affairs, QA, and Program teams.
Monitor post-market surveillance activities and regulatory commitments.
Respond to regulatory authority queries.
Identify regulatory risks and recommend mitigation strategies.
Support digitalization and process improvement initiatives using regulatory tools.
REQUIRED VERIFIED SKILLS
Life Sciences
Biomedical Engineering
Pharmacy
EU MDR
US FDA 510(k)
STED
CER
PMS
GSPR
Technical Documentation
COMPENSATION & REWARDS
₹12.0L - 20.0L per annum
The expected compensation range is ₹12 LPA to ₹20 LPA (CTC), reflecting market-competitive benchmarks for mid-level medical device regulatory specialists with specialized knowledge of EU MDR and US FDA 510(k) submissions.
ORGANIZATION CONTEXT & CULTURE
ZEISS India is actively hiring for this position.
INDUSTRY: Technology
EXPECTED CAREER ROADMAP
Joining ZEISS India as a Regulatory Affairs Specialist provides direct exposure to global medical technology compliance frameworks. Experienced specialists can advance into Senior Regulatory Strategy Lead, Global Regulatory Program Manager, or Quality & Regulatory Affairs Director roles across high-growth medtech and biomedical sectors.
APPLICATION ADVISORY
Highlight hands-on experience with technical file compilation (STED, GSPR, CER) and specific exposure to EU MDR or US FDA 510(k) pathways. Mentioning any RAC (Regulatory Affairs Certification) or experience in software/hardware medical device lifecycle management will strengthen your profile.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.