Pune Maharashtra Developer ii Jobs – 127 Open Jobs Today

Technical Lead - II_Pharma Compliance; Quality & Regulatory (Q&R)
CitiusTech Inc —Pune, Maharashtra
- APIs
- AI
- Communication skills
Senior Manager – Finance & Capital Closure
Suma Shilp —Pune, Maharashtra
- ₹70,000 - ₹1,50,000 a month
- Full-time
- Finance
- Master's degree
- Analysis skills
- Cell phone reimbursement
- Flexible schedule
Quick apply
6d
Software Engineer II (Software Engineer in Test )
Mastercard —Pune, Maharashtra
- Full-time
- Oracle
- Java
- SQL
Sr SF Developer
MiniMed —Pune, Maharashtra
- Full-time
- Salesforce
- DevOps
- Engineering
SDE II Conversational AI Developer- REMOTE
Full Potential Solutions —Pune, Maharashtra
- Remote
- Salesforce
- Project management
- Software development
- Health insurance
Software Engineer- Salesforce
Cornerstone OnDemand, Inc. —Pune, Maharashtra
- Computer Science
- Salesforce
- DevOps
14d
SRE II (L2 Tech Support+ Virtualization) 4-7Yrs Pune
Nutanix —Pune, Maharashtra
- Remote
- Computer Science
- Engineering
- Continuous improvement
Salesforce Consultant
ZS —Pune, Maharashtra
- Online application
- Salesforce
- Analysis skills
- Travel
- Work from home
FBS Agile Dev Team Member II
Capgemini —Pune, Maharashtra
- ₹1 a year
- Full-time
- Remote
- Computer Science
- B.Sc
- English
- Paid time off
Quick apply
Site Reliability Engineer II
Mastercard —Pune, Maharashtra
- Full-time
- Azure
- Software troubleshooting
- DevOps
Senior Salesforce Developer
RCG Global Services —Pune, Maharashtra
- Salesforce
- DevOps
- APIs
Quick apply
Senior Salesforce Developer (Product Engineering)
DataLunix Technologies —Pune, Maharashtra
- Full-time
- Salesforce
- DevOps
- APIs
Quick apply
7d
Senior Software Test Engineer II
ConnectWise —Pune, Maharashtra
- Computer Science
- Master's degree
- AWS
8d
Salesforce Agentforce Developer
NTT Ltd —Pune, Maharashtra
- Salesforce
- DevOps
- APIs
Salesforce Developer
Riskonnect —Pune, Maharashtra
- Full-time
- Salesforce
- DevOps
- Analysis skills
Quick apply
Senior Enterprise Software Engineer
Wolters Kluwer —Pune, Maharashtra
- Full-time
- Salesforce
- AI
- Communication skills
Data Engineer II
Mastercard —Pune, Maharashtra
- Full-time
- Azure
- Computer Science
- Java
Custom Software Engineer
Accenture —Pune, Maharashtra
- Full-time
- Salesforce
- DevOps
- APIs
Specialist II - Data Science
UST —Pune, Maharashtra
- System design
- Master's degree
- Databases
Quick apply
Senior Engineer
ZS —Pune, Maharashtra
- Online application
- Computer Science
- Salesforce
- English
- Work from home

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

CitiusTech Inc -
Pune, Maharashtra

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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.

Apply Now

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developer ii jobs in pune maharashtra

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

Senior Manager – Finance & Capital Closure

Software Engineer II (Software Engineer in Test )

Sr SF Developer

SDE II Conversational AI Developer- REMOTE

Software Engineer- Salesforce

SRE II (L2 Tech Support+ Virtualization) 4-7Yrs Pune

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FBS Agile Dev Team Member II

Site Reliability Engineer II

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Senior Salesforce Developer (Product Engineering)

Senior Software Test Engineer II

Salesforce Agentforce Developer

Salesforce Developer

Senior Enterprise Software Engineer

Data Engineer II

Custom Software Engineer

Specialist II - Data Science

Senior Engineer

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