
Lead Quality Assurance Regulatory Affairs
at Multinational engineering and technology company
Practice Head - QARA
Role - Delivery Manager- QARA
Experience: 15 to 20 Years
Location: Bangalore /Mysore
Notice period: Immediate to 45 days preferred
Mandate Skills:
- Electromechanical devices,
- IEC 62304, ISO13485, ISO14971, IEC 60601-1, FDA, EU,
- Lead Auditor, SaMD
- Delivery manager exposure
Job Description:
Provide leadership and direction to the Quality Assurance and Regulatory Affairs team.
Application of design controls.
Knowledge and experience in Quality Management System (ISO 13485, ISO 9001, MDSAP) in line with Corporate, Business Unit, and local requirements.
Compliance knowledge with EU IVDR 2017/746, EU IVDD 98/79, ISO 13485, MDSAP, ISO 9001, China MDR, ANVISA and USA 21 CFR part 820
Experience in conducting internal audits and supporting external & regulatory audits (FDA inspections) within the designated area of responsibility.
Engage with Global and commercial Regulatory teams to ensure regulatory activities are in alignment with business requirements
Experience with Supplier Quality Function to drive supplier quality at plant and Business Unit level.
Conduct Supplier Audits by Quality Assurance Agreements.
Contribute actively to defining IVD documentation, from user needs and applicable standards, to design verification testing, and give appropriate guidance to the development teams
Collaborate with QMS and regulatory specialist /managers /process owners in overseas offices (United states, Europe, China and other countries)
Review and provide regulatory impact assessments for product design changes (Reagent, Instruments and Software)
Creates and maintains Technical / Regulatory documentation (EU IVDR, EU IVDD 98/79/ec), US FDA 510 (k) submissions, and China Submissions (Software & Instrument& Reagent) and tracks the status, and progress of regulatory documentation
Work closely with Clinical Affairs to set up quality files suitable for submission to pre-market clinical investigation as required by Competent Authorities
Work in collaboration with the Legal team to prepare manufacturing and quality agreements with external providers and suppliers

Similar jobs
Responsibilities
- Responsible for managing and driving a team of Virtual Relationship Managers (VRM) handling a portfolio of eligible customers in order to achieve the targets set and that all guidelines and regulatory requirements are followed. Ensuring that customers get world-class services and their needs are understood and met through financial products that the Bank has to offer.
- Consistently meet portfolio objectives defined Viz. sales, income, group product holding etc.
- Ensure adherence to Operations process aimed at zero defect transaction processing & meeting the Audit & Compliance guidelines.
- Responsible for managing, training and motivating staff.
- All of the above parameters are consistently met by the team of VRMs.
- Income generation through the right blend of enhancement of CASA balance and cross-sell of appropriate products So that the VRM becomes the top of the mind recall amongst the customers in the catchment for all their financial needs and services, thereby ensuring that the VRMs also achieves the key performance parameters set 8. The team Manager leads a team of VRM (Virtual Relationship Manager) and is directly responsible for the performance of team members leading to the fulfilment of Business objectives.
- Monitoring and tracking the VRMs on revenue generation, product penetration, digital penetration, and liability growth and ensuring that the required product mix is maintained at the resource level to achieve the targeted number.
- The team Manager will be responsible for Sales Management through leads generated for a set of products from a fixed non-managed customer with the express objective of achieving business targets and efficiency targets related to outbound database calling management.
Requirements
- Bachelor's degree or equivalent experience.
- Minimum 4 years of team lead experience.
- Candidate should have a banking or voice process background.
- Willing to work from the office
Java 8 or later |
Primary |
Spring Framework |
Primary |
Rest API |
Primary |
Good knowledge in any Database (MySql, Oracle, or NoSQL) is mandatory. |
Primary |
Maven/Gradle/sbt |
Primary |
MQ/Kafka/RabbitMQ |
Primary |
Junit |
Primary |
Postman/Swagger/Jmeter |
Primary |
Enthusiastic to learn, |
Primary |
Good Programming, Coding, Basic DS/Algo Skill |
Primary |
Good Analytical Skill |
Primary |
Spring Boot |
Secondary |
Microservice |
Secondary |
No-SQL [Mongo, Cassandra] Preference on Cassandra |
Secondary |
Knowledge on Caching Framework like: Redis Or Apache Ignite. Preference on Apache Ignite |
Secondary |
Apache Kafka |
Secondary |
Azure DevOps/JIRA |
Secondary |
CICD Basic Knowledge |
Secondary |
Docker , Kubernates |
Secondary |
Scrum and Agile Methodology |
Secondary |
We believe in “the power of collaboration”, hence we are on a mission to consolidate the fragmented manufacturing base in the Indian speciality chemicals segment. We are a full-stack supplier of speciality chemicals and intermediates. Reliability, quality and affordability are the three pillars of our core values. Today, we are having a combined manufacturing capacity of ~ 5000 MTPA where over 50 chemicals are getting produced for various end industries i.e., personal care, pharma APIs, polymers, fragrances, agriculture etc. With a presence across diverse speciality chemical value chains and multiple production facilities, we are a one-of-a-kind and highly reliable one-stop-shop supplier to customers across the globe. We have been funded by a global Tier-1 venture capital fund (Lightspeed Venture Partners - $10B+ AUM fund and early investors in Oyo, Byju's, and Udaan) and have several renowned thought leaders and opinion shapers from the chemicals industry as advisors.
Job description:
1. Lead the Technical and Regulatory documentation for smooth operations.
2. Responsible for ensuring the accuracy and quality of COA, TDS, MSDS and other related technical documents.
3. Maintain a real-time database of Products & Suppliers with corresponding technical documents.
4. Mentor and guide the documentation team on writing practices and processes
5. Bring in strong Chemistry knowledge and support the demand and supply team with suitable inputs on specifications.
Our offering:
1. A great work environment with massive ownership and growth opportunities
2. Work closely with the founding and the leadership team on key projects
3. Opportunity to be on top of industry trends and learn from industry leaders.
4. Compensation: Market standards + ESOPs
- Looking for sr.java full stack developer
- java, springboot, angular 2/4/6/8, html and css
- experience with unit testing
- good exposure to oops
Requirements:
Strong development skills in Core / Advanced Java, and J2EE.
Knowledge of Bamboo, Jira, Spring AOP, Junit, SQL query optimization and fine tuning, is a
plus.
Strong analytical skills.
Good in Design Patterns.
Should have experience on JMS/Messaging and middleware like IBM MQ/Apache Kafka.
Strong in design and technical documentation.
Strong in Java SDK 1.8, Java SDK 11, Spring Boot (Embedded Tomcat), REST & SOAP API skills.
Strong in Spring frameworks (MVC, IOC, Boot, Batch) and ORM framework like Hibernate.
Hands-on experience in SQL.
Core Java, J2EE, SOA based Web Services, RESTful Web Services, Hibernate, Spring MVC,
XSD, XML and WSDL, DB, Microservices.
Understanding of Kafka and Netflix conductor.
Should have worked with Maven/Gradle, JIRA/Rally, Bamboo/Jenkins/Hudson.
Extensive development experience with Web Services (SOAP and REST).
Description
- Develop & support Robotic Process Automation (RPA) solutions that add value to DHL Express Functions.
- Manage the day-to-day activities pertaining to Robotic Process Automation (RPA) processes and solutions.
- Required preparation, update and regular review all relevant RPA documentation for the service line and the supporting/enabling functions
- Support the team in cultivating culture of continuous improvement and innovation
- Manage team administrative requirements for the team
- Designing practical and effective solutions to address improvement opportunities – both cost and performance.
- Successfully implement RPA initiatives with DHL Express Business Partners
- Ability to relate to cross-cultural processes and country sensitivities
- Responsible for process documentations (i.e. process maps)
- Qualified University Degree holder specializing in IT field (Software Development)
- At least 4+ years working experience in the Software Development Environment is preferred
- IT knowledge in software development process is a must
- Good understanding of IT development process
- Able to develop tools/solutions using programming language .Net and MSSQL
- Strong interest in Robotic Process Automation area
- Hands on experience on .Net Development will be added advantage
- Hands on experience on RPA tools UiPath,

Profile Overview:
We are looking for passionate and keen-eyed front-end developers with 5+ years of experience in React JS for a major project to join our creative front-end development team who can add optimization and efficiency to the user experience and maintain brand consistency across all web page of the web products.
The front-end developer will closely coordinate with our back-end developers, graphic designers and UI designers to ensure all elements of the web creation are consistent.
Responsibilities:
• Turning UI/UX designs into prototypes, creating excellent interactive forms of designs, writing reusable modules and maintainability of the code.
• Implement UI development principles to ensure that the product client-side serves at scale.
• Review and optimize the application usage by monitoring key metrics and rectifying the issues proactively.
• Determining the structure and design of web pages.
• Ensuring user experience by analyzing the design choices.
• Developing features to enhance the user experience.
• Striking balance between functional and aesthetic design.
Requirements:
- Bachelor’s or Master’s degree in computer science, computer applications or related fields.
- Proven working experience as a React Developer for 5+ years and above.
- Hands-on experience with HTML5, CSS3, and CSS frameworks.
- Demonstrable knowledge of Web services, Web API, REST services & GraphQL.
- Expertise in UI design and development of responsive web applications using React, Redux, Flask and Hooks.
- Applicable knowledge of Social API integration, Core location APIs, Web Views, Payments integration
- Proficiency in understanding layout aesthetics.
- Excellent analytical, problem-solving and multitasking skills.
- Ability to solve novel and challenging React problems.
- Capability to understand, develop and sustain continuous integration and delivery.
Vedantu is India's leading Online tutoring company which enables students to learn LIVE with some of
India's best-curated teachers. It’s a fast-growing EdTech start-up with an outreach to over 1 million
students spread across 1000+ cities from 30+ countries. Vedantu is founded by IITian friends who have
been teachers themselves with over 13 years of teaching experience. It caters to 6th grade to 12th grade, prepares students for school boards, and competitive examinations, and has co-curricular courses.
About the Role :
The academic Counselor is the face of Vedantu for all our students & parents and will help them understand
how to leverage the Vedantu Platform for their learning.
Roles & Responsibilities:
Will have to do consultative outbound calls & follow-up calls daily with prospective students & their parents.
Fix appointments and conduct demo sessions daily with prospective students & their parents.
Understand Customer profiles & learning problems to explain the implications of ineffective learning methods and create a need for Vedantu course offerings through a structured Counseling Session with the student and the parents.
Handle Objections and Price Negotiationnegotiations to generate Sales Revenue.
Learn/ Upgrade one’s Product Knowledge, Sales Skills, and market understanding to achieve and exceed growing Sales target(s).
Desired Profile of the candidate:
Should be proficient in English and Hindi.
Comfortable working with 6 days (Monday off) in a Fast-Paced Environment.
The Candidate should have a laptop with functional audio/video plugins.
In Addition to salary, there would be monthly Incentives based on Sales Performance
Minimum Qualification - Must be a Graduate
This Social Media Executive is suited for someone with an entrepreneurial spirit and wants to get a first-hand experience in various things that happen in a new organization. A candidate that doesn’t mind about living any challenging experience by owning it to self.
Candidate will be given responsibilities of supporting (including but not limited to) social media strategy planning, online advertising, promotions, & Ad-Campaigns. He/she will monitor and create aggressive marketing on Instagram & Facebook and create engaging content for blogs, forums and other social networks like Facebook, Twitter, Instagram, LinkedIn, Quora, Pinterest, etc.
He/she will optimize our website, blogs and social media content for maximum reach and impact (e.g. SEO/SEM) by using keyword analysis and cost/benefit analysis. They will develop a content calendar on a weekly and monthly basis.
Our company’s culture is unique in that we truly live by our values of friends first, integrity and doing the right thing.



Job Type: Full Time
Location: Permanent Remote / Bangalore / Thane
Skills: PYTHON, Django, Reactjs, Vue, Flask
Job Description
Are you passionate enough to be a crucial part of a highly analytical and scalable user engagement platform?
Are you ready learn new technologies and willing to step out of your comfort zone to explore and learn new skills?
If so, this is an opportunity for you to join a high-functioning team and make your mark on our organization!
The Impact you will create in the Job:
- Build campaign generation services which can send app notifications at a speed of 10 million a minute.
- Leverage the power of Kubernetes to maintain clusters running inside VPC's across the world.
- Dashboards to show Real time key performance indicators to clients.
- Develop complex user segmentation engines which creates segments on Terabytes of data within few seconds.
- Use AWS products extensively across our services such as Kinesis Data Streams, Lambda, SQS etc. that form an integral part of our scalable and robust infrastructure.
- As an individual contributor, you will tackle some of our broadest technical challenges that requires deep technical knowledge, hands-on software development, technical leadership, and seamless collaboration with all functions.
- You will envision and develop features that are highly reliable and fault tolerant to deliver a superior customer experience.
- You will get an opportunity to work with some of the best talent in the country while learning from various highly-functional teams in the company.
- Plan and execute the roadmap with the engineering team to build and deliver next-generation systems.
- You will also collaborate with cross-functional teams to meet deliverables throughout the software development lifecycle.
- Identify and improvise areas of improvement through data insights and research.
What we look for?
- 4-7 years’ experience in full stack Python development
- Very strong analytic and problem-solving skills
- Solid understanding of a relevant and globally supported framework- both front-end and back-end, if necessary, for example - Angular, React, Vue, or Django/Flask.
- Solid understanding of engineering best practices, continuous integration, and incremental delivery.
- Proven experience on design and implementation of the overall web and database architecture and updated knowledge on the latest practices and associated versions.
- Ensuring the entire stack is designed and built for speed and scalability.
- Familiarity with RESTful API design.
- Knowledge of continuous integration and deployment.
- Familiarity with Server management and deployment on AWS/GCE.
- Sound knowledge of CSS pre-processors, bundlers, and associated languages/syntaxes/libraries like Sass, Less, and webpack
- Experience implementing testing platforms and unit tests.
What’s in it for you?
- Immense growth, continuous learning and deliver the best to the top-notch brands
- Work with some of the most innovative brains
- Opportunity to explore your entrepreneurial mind-set
- Open culture where your creative bug gets activated.
If this sounds like a company you would like to be a part of, and a role you would thrive in, please don’t hold back from applying! We need your unique perspective for our continued innovation and success!
So let’s converse! Our inquisitive nature is all keen to know more about you.

