Regulatory Affairs Manager

zeissgroup; Bengaluru; On-site; INR 2,400,000 - 3,600,000; Full time

Job summary

ZEISS in India is seeking a Regulatory Affairs professional to lead APAC regulatory strategies for medical devices, ophthalmic lenses, eye drops, cosmetics, and dietary supplements across multiple markets.

You will coordinate lifecycle and change management, ensure alignment with global standards, and drive AI-enabled efficiencies in regulatory workflows across the APAC region. This role requires strong collaboration with QA, Operations, R&D, and clinical teams in a complex regulatory landscape.

Responsibilities

• Execute regulatory strategies for APAC markets aligned with global regulatory strategy
• Define regulatory pathways including classification, submission routes, and documentation requirements
• Ensure regional submissions comply with both local authority's expectations and global standards
• Tailor regulatory strategies to APAC markets, incorporating local reimbursement, market access, and competitive intelligence into regulatory planning
• Support and guide SSC RA teams to prepare, compile, and submit regulatory dossiers across APAC markets
• Support and guide SSC RA teams to manage authority interactions including deficiency responses, clarifications, and approvals
• Ensure consistency of dossiers with EU Technical Documentation / US FDA submissions where applicable and defined intended purpose of use
• Lead electronic submissions via country portals (NMPA, PMDA, TGA, HSA, CDSCO, MFDS), ensuring correct formats and data templates
• Assess regulatory impact of product and process changes across APAC country requirements
• EU MDR change control expectations
• US FDA design change regulations
• And other applicable regulations and standards
• Monitor and manage renewals, variations, and post-approval commitments
• Support global change control and ensure regulatory alignment across regions
• Coordinate lifecycle and change management across medical devices, cosmetics, and dietary supplements to ensure coherent APAC labeling and claims
• Maintain knowledge of EU MDR 2017/745 for technical documentation, PMS and vigilance
• US FDA regulations (21 CFR, 510(k), De Novo, PMA)
• MDSAP requirements and audit structure
• Be aware of EU/US expectations for ophthalmic devices and cosmetics and how they influence APAC requirements
• Support global audits and regulatory inspections as required
• Maintain data in RIMS/Document management: registrations, renewals, submissions, commitments
• Ensure data integrity, traceability, and audit readiness
• Hands-on experience with electronic submissions and lifecycle tracking, including templates, metadata, tagging and version control
• Maintain APAC RA dashboards and ensure submission packages are planned, archived for reuse, and compliant across APAC authorities
• Leverage AI to improve dossier compilation and structuring
• Gap assessment and document comparison
• Regulatory intelligence analysis
• Pre-validation of electronic submission packages before upload using AI or rules-based tools
• Ensure compliant use of AI tools with respect to data privacy, validation, and regulatory expectations
• Drive RA efficiency through AI, automation and digital tools
• Design and improve end-to-end digital submission workflows with IT and global RA
• Cross-functional Collaboration with QA, Operations, R&D, Clinical, Supply Chain

Job description

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 .

Primary duties and responsibilities

Regulatory Strategy & Execution (APAC with Global Alignment)

• Execute regulatory strategies for APAC markets aligned with global regulatory strategy
• Define regulatory pathways including classification, submission routes, and documentation requirements.
• Ensure regional submissions comply with both local authority's expectations and global standards.
• Tailor regulatory strategies to APAC market needs by incorporating local reimbursement, market access, and competitive intelligence considerations into regulatory planning for ophthalmic devices, lenses, eye drops, cosmetics, and dietary supplements.

End-to-End Submission Ownership

• Support and guide SSC RA teams to prepare, compile, and submit regulatory dossiers across APAC markets.
• Support and guide SSC RA teams to manage authority interactions including deficiency responses, clarifications, and approvals.
• Ensure consistency of dossiers with EU Technical Documentation / US FDA submissions where applicable and defined intended purpose of use.
• Lead or oversee (electronic) submissions via country‑specific digital portals and gateways (e.g. NMPA, PMDA, TGA, HSA, CDSCO, MFDS systems as applicable), ensuring correct use of local e‑submission formats, templates, and structured data requirements.

Lifecycle & Change Management

• Assess regulatory impact of product and process changes considering: APAC country requirements
• EU MDR change control expectations
• US FDA design change regulations
• And other applicable regulations and standards
• Monitor and manage renewals, variations, and post-approval commitments.
• Support global change control and ensure regulatory alignment across regions.
• Coordinate lifecycle and change management activities across multiple product categories (medical devices including lenses and ophthalmic devices, medicinal eye drops where applicable, cosmetics, and dietary supplements) ensuring coherent change strategies and consistent labeling and claims across APAC markets.

Global Regulatory Compliance Awareness

• Maintain working knowledge of: EU MDR (2017/745) requirements for technical documentation, PMS, and vigilance
• US FDA regulations (21 CFR, 510(k), De Novo, PMA pathways)
• MDSAP requirements and audit structure
• Ensure APAC regulatory strategies are aligned with global submissions and compliance frameworks.
• Maintain awareness of how EU and US regulatory expectations for ophthalmic devices, intraocular lenses, contact lenses, eye drops, cosmetics and dietary supplements influence APAC requirements (e.g. reliance pathways, recognition of FDA/MDR approvals, MDSAP‑based inspections).
• Support global audits and regulatory inspections when required.

RIMS (Regulatory Information Management System)

• Maintain accurate and complete data in RIMS or Doc management systems (registrations, renewals, submissions, commitments).
• Ensure data integrity, traceability, and audit readiness.

Hands‑on experience with (electronic) submission preparation and lifecycle tracking, including use of templates, metadata, tagging, and version control to support efficient initial submissions, responses to authority queries, and resubmissions.

• Maintain APAC RA dashboards and regularly keep them updated, Example: Turn around time for submission, Labeling, etc Ensure that (electronic) submission packages (dossiers, data sets, labeling) are planned and archived in a way that supports reuse, reformatting, and resubmission for multiple APAC authorities, including management of country‑specific registration IDs, license numbers, and expiry dates in RIMS.

AI-Driven Regulatory Excellence

• Leverage AI tools to improve efficiency in: Dossier compilation and structuring
• Gap assessment and document comparison
• Regulatory intelligence analysis
• Pre‑validation of electronic submission packages (e.g. structure, metadata, completeness checks) prior to upload into authority portals, using AI or rules‑based tools where appropriate.
• Ensure compliant use of AI tools with respect to data privacy, validation, and regulatory expectations.
• Bring more operational efficiency in RA domain by leveraging AI, Automation and other digital tools
• Ability to design and continuously improve end‑to‑end (digital) submission workflows (from authoring to authority upload and archival) in collaboration (with IT) and global RA, ensuring data integrity and inspection readiness.

Cross-functional Collaboration Collaborate with QA, Operations, R&D, Clinical, Supply Chai