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11+ FDA Jobs in Pune | FDA Job openings in Pune

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NeoGenCode Technologies Pvt Ltd
Akshay Patil
Posted by Akshay Patil
Bengaluru (Bangalore), Pune
5 - 10 yrs
₹2L - ₹12L / yr
Medical devices
sustenance
DHF Remediation
ISO 13485
IEC 60601
+11 more

Job Title : Medical Device Engineer

Location : Bangalore / Pune

Experience : 5+ Years total, with at least 3 years in Medical Device Development, Sustenance, or DHF Remediation

Notice Period : Immediate to 1 week

Interview Process : L1-selected candidates will undergo a customer interview


Mandatory Skills : Medical Device Development/Sustenance/DHF Remediation, ISO 13485, IEC 60601, ISO 14971, FDA & EU MDR compliance, DHF documentation, Design FMEA, CTS/CTQ, QMS, PLM, Verification & Validation, Impact Assessment.


Key Skills & Knowledge :

  • Strong understanding of ISO 13485, IEC 60601, and ISO 14971 standards
  • Experience with FDA and EU MDR regulatory requirements

Responsibilities :

  • Conduct gap assessments and create/update DHF documents, including user and product requirements, design FMEA, CTS/CTQ, and standards compliance reports
  • Analyze and implement design changes, assess impact, and update documentation accordingly
  • Identify gaps in verification and validation, ensuring clear traceability between requirements and verification documents
  • Assess compliance with applicable standards and regulations
  • Define CTS/CTQ parameters and actively participate in design reviews
  • Follow QMS guidelines and manage changes through PLM.
Read more
DocNexus
Mahek Chhatrapati
Posted by Mahek Chhatrapati
Remote, Hyderabad, Pune
2 - 10 yrs
₹10L - ₹25L / yr
SQL Query Analyzer
Big Data
Customer Support

At DocNexus, we’re revolutionizing how life sciences companies search and generate insights. Our search platform unlocks powerful insights, and we're seeking a Customer Success Team Member with strong technical skills to help our customers harness its full potential.

What you’ll do:

  • Customer Support: Troubleshoot and resolve customer queries, particularly around referral reports, data anomalies, and data generation using our platform.
  • Data Queries (BigQuery/ClickHouse): Respond to customer requests for custom data queries, working with large datasets in BigQuery and ClickHouse to deliver precise insights.
  • Onboarding & Training: Lead onboarding for new customers, guide teams on platform usage, and manage access requests.
  • Listen & Improve: Collect and act on customer feedback to continuously improve the platform, collaborating with the product team to enhance functionality.
  • Technical Documentation: Assist with technical resources and help create training materials for both internal and customer use.

What you bring:

  • Strong Technical Skills: Proficient in querying with BigQuery and ClickHouse. Comfortable working with complex data, writing custom queries, and resolving technical issues.
  • Customer-Focused: Excellent communication skills, able to translate technical data insights to non-technical users and provide solutions clearly and effectively.
  • Problem-Solver: Strong analytical skills and a proactive mindset to address customer needs and overcome challenges in a fast-paced environment.
  • Team Player: Work collaboratively with both internal teams and customers to ensure success.

If you're passionate about data, thrive in a technical environment, and are excited to support life sciences teams in their data-driven decision-making, we'd love to hear from you!

Read more
B2B Product

B2B Product

Agency job
via Scaling Theory by Keerthana Prabkharan
Remote, Pune
14 - 20 yrs
₹25L - ₹50L / yr
GRC
EMC RSA Archer
ServiceNow
Implementation
ISO/IEC 27001:2005
+2 more

What will you do?

Governance and Policy Development   

·         Develop, implement, and maintain governance policies, SOPs, and related documentation. 

·         Ensure all policies align with industry standards (e.g., FedRAMP, NIST SP 800-53, ISO 27001 family, and HIPAA). 

·         Monitor policy effectiveness and recommend updates based on organizational changes or regulatory updates. 

Risk Management   

·  Conduct risk assessments to identify vulnerabilities, threats, and compliance gaps. 

·  Collaborate with cross-functional teams to design and implement remediation strategies. 

·  Maintain risk registers and monitor mitigation efforts. 

Compliance Oversight   

·  Support the organization in achieving and maintaining FedRAMP certification. 

·  Manage periodic audits, security assessments, and readiness activities for compliance frameworks. 

·  Track and report on compliance metrics, audit findings, and resolution status. 

Training and Awareness   

·  Develop and deliver training programs to enhance employee understanding of compliance policies and procedures. 

·  Act as a point of contact for compliance-related queries within the organization. 

Incident Response and Reporting   

·  Support incident response processes to ensure effective investigation and reporting of compliance-related incidents. 

·  Collaborate with stakeholders to implement corrective actions and prevent recurrence. 

Vendor and Third-Party Risk Management   

·  Assess third-party vendors for compliance with organizational policies and standards. 

·  Ensure contracts include appropriate compliance requirements. 

What do you bring to the table?

Education & Experience   

·  Overall 12- 15 years of relevant experience

·  Bachelor's degree in Information Technology, Cybersecurity, Risk Management, or related field (Master’s preferred). 

·  3+ years of experience in governance, risk, and compliance roles, with specific experience in FedRAMP compliance.  

Knowledge & Skills   

·  Strong understanding of FedRAMP, NIST SP 800-53, ISO 27001, and other relevant frameworks. 

·  Experience in drafting policies, procedures, and SOPs. 

·  Familiarity with GRC tools and platforms (e.g., Archer, ServiceNow GRC). 

·  Excellent communication and documentation skills. 

·  Analytical mindset with attention to detail. 

Certifications (Preferred)   

·  Certified Information Systems Security Professional (CISSP) 

·  Certified Information Systems Auditor (CISA) 

·  Certified Information Security Manager (CISM) 

·  ISO 27001 Lead or Internal auditor

Read more
Espressif Systems India Pvt Ltd
Anuja Pawar
Posted by Anuja Pawar
Pune
6 - 10 yrs
₹15L - ₹25L / yr
skill iconJavascript
skill iconReact.js
skill iconHTML/CSS
skill iconRedux/Flux

 

About Company: 

Espressif Systems (688018) is a public multinational, fabless semiconductor company established in 2008, with headquarters in Shanghai and offices in Greater China, India, and Europe. We have a passionate team of engineers and scientists from all over the world, focused on developing cutting-edge Wi-Fi and Bluetooth, low-power IoT solutions. We have created the popular ESP8266 and ESP32 series of chips, modules, and development boards. By leveraging wireless computing, we provide green, versatile, and cost-effective chipsets. We have always been committed to offering IoT solutions that are secure, robust, and power-efficient. By open-sourcing our technology, we aim to enable developers to use Espressif’s technology globally and build smart connected devices. In July 2019, Espressif made its Initial Public Offering on the Sci-Tech Innovation Board (STAR) of the Shanghai Stock Exchange (SSE). 

Espressif has a technology centre in Pune. The focus is on embedded software engineering and IoT solutions for our growing customers.

About Role: 

https://rainmaker.espressif.com/">ESP RainMaker provides a complete solution to makers to develop connected devices with ease. It also focuses on solving a major challenge about how the quality of connected devices can be improved. It constitutes device-side SDK, mobile apps and a cloud application. This role requires product engineering for the web UI for the RainMaker cloud.

Minimum Qualification: 

  • BE/B.Tech in Computer Science with 5 to 10 years of experience
  • Strong Computer Science Fundamentals
  • Excellent understanding of UX and design sensibilities
  • Design, develop, and test UI for web applications
  • Experience with one or more of these: React, Redux, Webpack, ES6, Async JS Communication, WebSockets
  • Strong debugging and troubleshooting skills

Desired Qualification:

  • Significant experience with JavaScript, React and Redux.
  • Experience in consumption of cloud services and REST interfaces (implementation experience would be added advantage)
  • Experience with CSS pre-processors like LESS or SASS
  • Expertise with cross-browser, cross-platform, and responsive design
  • Solid understanding of user interactions required for Single-Page Applications
  • Experience with modern browser technologies

 

Responsibilities: 

  • Designing and developing User Interface for web applications
  • Write code based in HTML, CSS, JavaScript and ReactJS
  • Accurately translate user and business needs into functional, secure and efficient frontend design and code
  • Experience and desire to take product/feature ownership from delivery and customer support perspective
  • Collaborate with backend and quality engineers to spec, write, test, and deploy code that integrates with data streams and API endpoints
  • Utilise responsive design techniques and ensure cross-browser compatibility
  • Perform code reviews and improve/ensure the quality of product

What to expect from our interview process

  • The first step is to email your resume or apply to the relevant open position, along with a sample of something you have worked on such as a public GitHub repo or side project etc.
  • Next, post shortlisting your profile recruiter will get in touch with you via a mechanism that works for you e.g. via email, phone. This will be a short chat to learn more about your background and interests, to share more about the job and Espressif, and to answer any initial questions you have.
  • Successful candidates will then be invited for 2 to 3 rounds of the technical interview as per the previous round feedback.
  • Finally, Successful candidates will have an interview with HR.

What you offer us

  • Ability to provide technical solutions, support that fosters collaboration and innovation.
  • Ability to balance a variety of technical needs and priorities according to Espressif’s growing needs.

What we offer

  • An open-minded, collaboration culture of enthusiastic technologist.
  • Competitive salary
  • 100% company paid medical/dental/vision/life coverage
  • Frequent training by experienced colleagues and chances to take international trips, attend exhibitions, technical meetups and seminars.
Read more
Na

Na

Agency job
via Method Hub by Sampreetha Pai
Pune, Bengaluru (Bangalore)
8 - 10 yrs
₹18L - ₹24L / yr
TOGAF

1. 8 to 12 of total IT experience and has full exposure of end-to-end SDLC

2. 1 to 2 years of experience as Solution Architect

3. Should have basic understanding in Architecture methodologies like TOGAF

4. Should have working knowledge of working in Architecture tools like Visio or any other EA tool

5. Should have experience in delivering Architecture artifacts diagrams like Business Architecture, Application Architecture and Deployment Architecture

6. Experienced and implemented solutions for Architecture patterns like Microservices, Event driven, REST API’s

7. Ability to illicit both functional and Non-functional requirements for business

8. Able to provide Solutions to address all NFR requirements like Scalability, performance, Security, Availability (HA/DR and other concepts) and Resiliency (RTO/RPO and other concepts)

9. Understanding of various network protocols- HTTPS, TCP/IP etc., Authentication mechanisms like LDAP etc.

Read more
IT MNC

IT MNC

Agency job
via People First Consultants by Aishwarya KA
Bengaluru (Bangalore), Mumbai, Delhi, Noida, Pune, Hyderabad, Chennai, Kolkata, Kochi (Cochin)
5 - 14 yrs
Best in industry
Pega
Pega PRPC
RESTful APIs
SOAP
CSA
+1 more

Greetings!


Hiring the below position for one of our premium client.


Role: PEGA Developer

Experience: 5-15 years

Location: PAN India

Certification: CSA & CSSA mandatory


  • 4.5 - 9 of experience in Pega Development with Pega relevant certification.
  • Working experience in Pega PRPC and Pega layer cake structure, class structure rule resolution ruleset structure, portals views and harness components.
  • Basic data storage and database query knowledge through Pega.
  • Good knowledge around integration and exposure to REST and SOAP APIs.
  • Good to have knowledge and experience on at least one Pega Industry framework.
  • Should be able to track and manage own tasks.
  • Should have very good verbal and written communication
Read more
An international MNC specialized into Hardware & Networking

An international MNC specialized into Hardware & Networking

Agency job
via Tridat Technologies Pvt. Ltd. by Shraddha Kamble
Mumbai, Navi Mumbai, Pune
4 - 10 yrs
₹4L - ₹10L / yr
MS Exchange Server
Office 365
English Proficiency

Hello,

 

Greetings for the day !!!

 

We are hiring "Technical Support L3 - Exchange Server" for one of the international MNC specialized into Hardware & Networking based @ Mumbai/Pune !!!

 

Position: Technical Support L3 - Exchange Server

 

Must Have Skills

Exchange Server, O365

 

Experience Level: 4+ Years

 

Required Skills

  1. Knowledge of Exchange Management & troubleshooting.
  2. Knowledge of Office 365 Management & troubleshooting.
  3. Knowledge of Active Directory management & troubleshooting.
  4. Knowledge of mail routing and client connectivity.
  5. Knowledge of Back up configuration & troubleshooting.
  6. Well versed with Windows event log & analysis.
  7. Enthusiasm for learning new skills.
  8. Good communication skills - both written and verbal.
  9. Passion for providing exceptional service to customers.
  10. Strong sense of ownership and accountability.
  11. Strong work ethics.

 

Roles & Responsibility:

  1. Expert knowledge of Exchange 2010, 2013, 2016, and 2019 its troubleshooting.
  2. Advanced Knowledge of handling Office 365 issues.
  3. Advanced Knowledge of Active Directory Replication, Permission Management, Group Policy, and troubleshooting will be added advantages.
  4. Must have a minimum of 4 years working experience and intimate proficiency with Microsoft Exchange 2010, 2013, 2016, and 2019 administration and troubleshooting in a large-scale multi-site environment.
  5. Must have skills in deploying Exchange in a large enterprise environment.
  6. Knowledge of Exchange Hardening.
  7. Expert knowledge of mail flow and third-party smart host filtering.
  8. Expert knowledge of Outlook and OWA configuration and troubleshooting.
  9. Expert knowledge in Troubleshooting issues by checking Exchange Logs and Windows Event Logs.
  10. Advanced knowledge in a clustered environments (Windows Cluster / DAG).
  11. Expert knowledge in Backup Applications with respect to Active Directory and Microsoft Exchange 2010, 2013, 2016.
  12. Good to have knowledge of Azure.

 

Employment Mode: Permanent Opportunity

 

Work Mode: Work from office

 

Shift: 24*7 Rotational Shift

 

Location: 

Mumbai - Andheri

Pune - Hinjewadi Phase 2

Read more
Spry Healthcare
Palka Sethi
Posted by Palka Sethi
Pune
2 - 4 yrs
₹15L - ₹25L / yr
Product Management
us healthcare
API
Business Analysis
SaaS
+4 more
Location - Pune (Work from Office)
Experience - 4 – 6 years
About the role –
The Product Manager role will report to the CEO and will build the product from 0 to 1.
Responsibilities
 Need to work with the senior management team to work on product roadmap
 Work with tech and management to create and execute product pipeline
 Own the successful delivery of your roadmap and co-own the success of the overall products
 Define requirements (JIRA) - Creating EPICs, user stories. Tracking the sprint
 Effectively identify and manage cross-team dependencies
 Ensure delivery timelines

Required Knowledge and Skills

 Should have good understanding of eligibility, Prior authorization workflows
 worked as product lead/lead BA
 Worked on eligibility implementation (API Integration) ( Waystar, Change healthcare, Claim MD etc.)
 Should have experience in building and scaling SaaS tools from the ground up.
 Excellent communication and collaboration skills
 Use common tools to create mockups, stories, and roadmaps Preferred Qualifications
 3+ Years of product management experience, including cloud/SaaS product

US Healthcare Experience

 Value added - If worked on X12 270, 271

Basic Qualifications
 Bachelor’s engineering degree from Tier 1 institute
 MBA from Tier 1 (good to have)
 3 Years of product management experience, including cloud/SaaS product
Read more
Reliance Brands Ltd.
Nazim Kapadia
Posted by Nazim Kapadia
Mumbai, Navi Mumbai, Delhi, Gurugram, Noida, Chandigarh, Surat, Pune, Ahmedabad, Chennai, Kochi (Cochin), Bhopal, Indore, Patna, Kolkata, Lucknow
0 - 3 yrs
₹1L - ₹2L / yr
Customer Service
Retail
Know your customer
Customer Success
Sales
+2 more

About Hamleys:

Hamleys is not just a Toy Store but an entire Toy experience. Currently there are more 125 stores in India and we are present in more than 20 countries. 365 days of play is the brand philosophy of Hamleys. At Hamleys we believe in giving our customers an Instore experience that helps him build memories for lifetime.

 

Job Title: Fun Consultant

Grade: A1

Role:

  • Warmly welcome and approach each customer – customer’s inclination to shop starts right from the first step & eye contact.
  • Believes and lives the attitude of “Sheer customer delight” – go beyond
  • To efficiently adhere to all “company procedures and policies.”
  • To work with the team to achieve award winning “customer service.”

Key Responsibilities:

  • Contribute to achieve store KPIs.
  • Utilize the knowledge of trends and guide each customer on “what suits better” – in line with the customer needs, individuality and product range.
  • Believes and lives the attitude of “Sheer customer delight” – go beyond

Desired Skills & Abilities

  • Superior understanding of Indian retailing and global trends.
  • Good communication and interpersonal skills - understand customer needs
  • Good at relationship building - conversion to sales
  • Ability to follow brand and store guidelines
  • Good operations experience – receiving stock, inventory keeping, cash handling etc.
Read more
Oddr

at Oddr

Sumit Garg
Posted by Sumit Garg
Remote, Pune
3 - 5 yrs
₹10L - ₹20L / yr
skill icon.NET
ASP.NET
skill iconC#

Oddr is looking for a skilled backend engineer to help us build scalable multi-tenanted enterprise Cloud applications. The ideal candidate should be able to bring new ideas to the table and design and develop distributed microservices with a strong emphasis on security, resiliency, scalability, performance, and quality. The candidate should be a self-motivated team player and take pride in what they deliver.

 

The candidate should be interested in a long-term stable career to grow with our company. The candidate will need to work late night hours because of the geographic distribution of the team.

 

Requirements:

  • Strong understanding of .NET Core and C#
  • Knowledge of Cloud development concepts
  • Experience with successful end-to-end delivery of web applications in the Cloud. Azure knowledge is a strong plus.
  • Experience with API-driven development and developing RESTful APIs
  • Experience with database design and writing complex SQL
  • Ability to write clean, well-structured code with adequate test coverage, proper abstraction, and reusability
  • Ability to work to tight deadlines, manage priorities, and take responsibility for delivering to time and quality requirements
  • Good understanding and experience with Agile development methodologies
  • Excellent communication skills
  • Excellent problem-solving skills

 

Minimum qualifications required:

  • Bachelor's degree or relevant certification from a reputable institute.
  • 3-5 years of experience.
Read more
Veridical Consultancy Services
Pune
1 - 3 yrs
₹1L - ₹3L / yr
Recruitment/Talent Acquisition
Human Resources (HR)
Performance Evaluation
Training and Development
Compensation & Benefits
+2 more
1) Sourcing, Screening & Identifying the most eligible candidate as per client requirements (IT and Non-IT) by using the Internet search & Job Posting, Mass Mailing, Head Hunting at Portals such as Naukri, Monster, Times Jobs, Linkedin & through References. 2) Conducting the preliminary interviews either telephonically or through direct interaction. 3) Briefing the candidates regarding the job profile, salary package and client organization etc. 4) Coordinating with the candidates all over India through mail and phone. 5) Follow up on interview status and update candidate on the same. 6) Organizing & coordinating with the clients for the interview process up to final closure/selection. 7) Scheduling and coordinating Interviews. 8) Maintaining relationship with clients & candidates. 9) Maintaining candidate’s database. 10) Responsible for full life cycle of recruitment. 11) Mapping client’s manpower requirements, coordinating and ensuring the right candidates at the right job
Read more
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