Maharashtra Manager (electronic security) Jobs – 134 Open Jobs Today

Technical Lead - II_Pharma Compliance; Quality & Regulatory (Q&R)
CitiusTech Inc —Pune, Maharashtra
- APIs
- AI
- Communication skills
Senior Tech Lead Mechatronics
Emerson —Pune, Maharashtra
- Full-time
- Master's degree
- C++
- Electrical experience
Custom Software Engineering Lead
Accenture —Pune, Maharashtra
- Full-time
- Computer Science
- System design
- Master's degree
Lead Engineer- Electronics
Mahindra & Mahindra Ltd —Chakan, Pune, Maharashtra
- Master's degree
- Bachelor's degree
- Electrical Engineering
9d
Lead Engineer - Software (C#)
Eaton —Hadapsar, Pune, Maharashtra
- Azure
- Computer Science
- DevOps
Franchisee*Franchisee*N.A.-Territory Manager
Kotak Securities —Pune, Maharashtra
- Master's degree
- Analysis skills
- Communication skills
Team Lead - Embedded (UI)
Legrand Group —Thane District, Maharashtra
- Full-time
- Computer Science
- Master's degree
- C++
Quick apply
Associate Test Lead - Automation (Selenium, Playwright, Appium)
NEC Software Solutions (India) —Mumbai, Maharashtra
- Full-time
- Azure
- DevOps
- Java
Quick apply
Technical Lead Microsoft Dynamics 365 F&O
Datafortune —Pune, Maharashtra
- Full-time
- Azure
- SQL
- APIs
7d
Lead Software Engineer
Nomura —Mumbai, Maharashtra
- Java
- Master's degree
- SQL
Lead Analyst - Ignition Full Stack
Eaton —Pune, Maharashtra
- Software troubleshooting
- Windows
- Master's degree
Lead Software Engineer
Mastercard —Pune, Maharashtra
- Full-time
- Java
- Master's degree
- AWS
Senior Tech Lead Hardware design Engineer
Emerson —Pune, Maharashtra
- Full-time
- Schematics
- Bachelor's degree
- Mentoring
- Health insurance
Lead Firmware Engineer
Emerson —Pune, Maharashtra
- Full-time
- Azure
- Master's degree
- C++
Lead Software Engineer (Connex)
Mastercard —Pune, Maharashtra
- Full-time
- Java
- Agile
- Communication skills
Team Lead — Full-Stack & AI/IoT Engineering
UVK Link Pvt. Ltd —Nashik, Maharashtra
- ₹3,79,554.66 - ₹6,31,624.32 a year
- Full-time
- Azure
- Computer Science
- ERP systems
- Paid time off
- Work from home
Quick apply
Technical Leader – Embedded Software Development
Emerson —Pune, Maharashtra
- Full-time
- Azure
- DevOps
- English
Sales Manager
SB Data Systems Private Limited —Mumbai, Maharashtra
Lead Data Engineer - Data Engineering 4C
Genpact India Pvt. Ltd. —Pune, Maharashtra
- Full-time
- Hybrid work
- Azure
- Oracle
- Computer Science
Quick apply

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Technical Lead - II_Pharma Compliance; Quality & Regulatory (Q&R)

CitiusTech Inc -
Pune, Maharashtra

Apply Now

Job details

Qualifications

PaaS
APIs
AI
Communication skills
IaaS
FDA regulations
SDLC

Full job description

Job ID: 874468

7 - 10 Years

1 Opening
CT Pune Qubix SEZ1

Role description

"Serve as the hands‑on Regulatory & Compliance Lead for Healthcare & Life Sciences (HLS) software products—covering cloud-based, on‑premise, and web applications. Own the complete regulatory‑compliance documentation lifecycle and guide engineering teams to produce regulatory‑grade, audit‑ready evidence. This role requires strong understanding of regulatory documentation frameworks used in FDA 510(k) submissions and EU MDR Annex II/III technical documentation, combined with hands‑on experience in validation, data integrity, Part 11/Annex 11, and GAMP 5 risk‑based compliance frameworks. Imaging domain knowledge is a strong plus" Key Responsibilities Regulatory Documentation Ownership Create, structure, and maintain all documentation required for HLS software regulatory submissions, including sections defined in FDA 510(k) submission guidelines such as software description, architecture, verification/validation, cybersecurity, and substantial equivalence analysis. [fda.gov] Prepare documentation aligned with the EU MDR Annex II & III technical documentation structure, including system description, design & development evidence, V&V summaries, risk management traceability, and labeling/IFU inputs. [fda.gov] Develop regulatory checklists for cloud and non‑cloud software (SaaS/PaaS/IaaS, hybrid, and standalone apps). Compliance & Validation Leadership Lead creation of GxP/regulated system documentation following GAMP 5 risk‑based lifecycle guidance, ensuring traceability from URS design testing validation evidence release. [tuvsud.com] Implement & document controls for 21 CFR Part 11 (electronic records/signatures) and EU Annex 11 (computerized systems) including audit trails, security, data integrity (ALCOA+), and system lifecycle control. [gmp-compliance.org], [fda.gov] Create validation deliverables independently: URS, risk assessments, IQ/OQ/PQ protocols, test results, periodic review documentation, and change control validation impact assessments. Cross‑Functional Technical Guidance Work closely with engineering teams to help them produce regulatory‑ready artifacts, including but not limited to - Architecture diagrams Data flow & audit trail mapping Cybersecurity documentation for FDA submissions (per 510(k) guidance) Verification & validation evidence Risk mitigations tied to ISO 14971 Translate regulatory requirements into implementable tasks for developers and QA teams. Regulatory Readiness for Cloud & Web Platforms Guide teams on compliance expectations for: Cloud‑hosted HLS platforms Multi‑tenant SaaS architectures Deployed AI/ML features (if applicable) APIs, microservices, and data flows impacting regulated functions Ensure documentation aligns to software‑specific sections in 510(k) and EU MDR frameworks for devices/software. Audit & Inspection Preparedness Prepare audit‑ready documentation packages for internal QA, client assessments, and regulatory audits. Act as compliance SME during audits, leveraging knowledge of predicate rules and system validation frameworks defined under FDA Part 11 and EU Annex 11. Required Skills & Experience 8–14 years in regulatory, software compliance, CSV, or HLS technology roles. Deep practical knowledge of: FDA 510(k) submission structure & evidence expectations (software documentation, cybersecurity, V&V) [fda.gov] EU MDR Annex II/III technical documentation frameworks for software [fda.gov] 21 CFR Part 11 controls for e‑records/e‑signatures [gmp-compliance.org] EU Annex 11 for computerized systems (security, validation, data integrity) [fda.gov] GAMP 5 validation lifecycle and risk‑based approach [tuvsud.com] Strong understanding of SDLC, cloud architectures, and documentation needs for SaaS and regulated web apps. Ability to independently produce high‑quality regulatory content (not just review). Strong cross‑functional communication — able to guide engineers, QA, product, and security.

About CitiusTech

CitiusTech is a global technology services, consulting, and business solutions enterprise 100% focused on the healthcare and life sciences industry. We enable 140+ enterprises to build a human-first ecosystem that is efficient, effective, and equitable. Leveraging deep domain expertise and next-generation technologies including AI, Cloud, Data, and Intelligent Automation, we assist our clients to realize their vision, accelerate transformation, and achieve business outcomes. With 7,700+ healthcare technology professionals worldwide, CitiusTech powers digital innovation, business transformation, and industry-wide convergence through next-generation technologies, solutions, and products.

Apply Now

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manager (electronic security) jobs in maharashtra

Technical Lead - II_Pharma Compliance; Quality & Regulatory (Q&R)

Senior Tech Lead Mechatronics

Custom Software Engineering Lead

Lead Engineer- Electronics

Lead Engineer - Software (C#)

FranchiseeFranchiseeN.A.-Territory Manager

Team Lead - Embedded (UI)

Associate Test Lead - Automation (Selenium, Playwright, Appium)

Technical Lead Microsoft Dynamics 365 F&O

Lead Software Engineer

Lead Analyst - Ignition Full Stack

Lead Software Engineer

Senior Tech Lead Hardware design Engineer

Lead Firmware Engineer

Lead Software Engineer (Connex)

Team Lead — Full-Stack & AI/IoT Engineering

Technical Leader – Embedded Software Development

Sales Manager

Lead Data Engineer - Data Engineering 4C

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