Regulatory Affairs Excellence Specialist jobs at Philips in India, Bengaluru

What can you expect:

• Based in North Ryde, with free onsite parking or close to transport.

• Flexible and hybrid working environment.

• Full time role, working with a great and supportive team.

• Attractive salary package, benefit and even staff discount on Philips products

• Long term career growth opportunities and development

You're the right fit if:

• First of all, you pride yourself on your customer service skills and approach your work with a sense of urgency with each interaction where you are able to coordinate and negotiate for best customer experience and outcomes.

• You will have previously held a focused customer service, coordinator position which has been fast paced such like high volume call centre, loan equipment or previous services scheduler experience would be great.

• Excellent organisation and time management, have a sense of urgency and able to prioritize and reprioritize throughout your day.

• Great Stakeholder engagement skills, you build strong relationships with different teams and customers to enhance collaboration and outcomes.

• You will hold at minimum High School Certificate, Diploma, Vocational Education as a minimum and or Bachelor's Degree in Business Operations, Supply Chain Management, Operations or equivalent

Job Title :

In this role, you have the opportunity to

• Ensures that appropriate SW Quality plans are made that include all stages of the software life cycle and supports SW Quality Plan design

• Validates key design inputs like: usability, reliability, performance,

• supportability,

• serviceability,sustainability and costs

• Provides effective oversight of: the execution of the SW Quality Plan and any Risk Management activities, and of all design related activities during the software lifecycle

You are responsible for

• To lead quality related problem solving for software

• Use post-market analytics and statistics to report on software performance in the field (provide feedback to manufacturing, suppliers or design teams) and

• initiate field actions when required

• Act as a single point of contact (person assigned to project team) responsible

• to ensure that software design quality relatedrequirements/criteriaare completed and meet SW Quality standards for every PRP milestone

• Make a substantial contribution to ways of combining Agile withmedical softwaredevelopment

To succeed in this role, you should have the following skills and experience

• Working knowledge of appropriate global medical device regulations, requirements and standards. consumer product regulations, industry. standards, such as 21 CFR Parts 803, 806 and 820

• 8-10 years of work experience in a related field

• Experience in IEC 62304 and software quality experience mandatory

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Our hybrid working model is defined in 3 ways:

- Design, develop, and operate internal Code Hub Platform Engineering services on top of our AWS/GitHub/Artifactory foundational layer.
- Implement infrastructure-as-code and automation pipelines using Terraform, GitHub Actions, and other DevOps tools.
- Lead or co-lead improvements in scalability, reliability, and developer experience for mission-critical services.
- Monitor and continuously improve service performance, cost-efficiency, observability, and compliance with SRE best practices.- Contribute to and support the Backstage Developer Portal as a gateway to platform capabilities and self-service workflows.
Bachelor's / Master's Degree in Computer Science, Software Engineering, Information Technology or equivalent.
- 10+ years of hands-on software engineering experience with proficiency in at least one modern language (e.g., TypeScript, Python, Java, or C#).
- Experience with cloud-native development and deployment, especially on AWS (e.g., ECS, Lambda, S3, CloudWatch).
- Experience designing, securing, and scaling CI/CD pipelines using GitHub, GitHub Actions, and infrastructure-as-code tools.
Master's Degree in Computer Science, Information Technology or equivalent
- Comfortable working with container-based systems (e.g., Docker, Kubernetes) and modern observability tooling.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .

Your responsibilities include the following:

• Identify / prospect opportunities for new customer acquisition
  • Define and execute account strategy across a range of customer accounts (e.g., conduct market and competitor research)
  • Drive effective funnel management to build towards sales targets and Philips business objectives
  • Collaborate with and engage Specialists and Business unit leaders during key portions of the sales process
• Establish meaningful customer partnerships
  • Engage with a range of customer partners to identify new business opportunities (from clinical stakeholders to C-suite, incl channel partners)
  • Develop a comprehensive understanding of a customer’s current and future needs, and identify how opportunities for the EI portfolio to meet their needs
  • Tailor talk tracks to demonstrate the value of the EI portfolio with high potential new accounts
  • Partner with Sales Specialists to provide customers with deep product expertise during the sales cycle
• Lead contract negotiations to secure mutually beneficial terms
• Collaborate with Philips sales leaders to deliver on shared EI business objectives
• Maintain Salesforce.com hygiene to enable effective reporting and forecasting

To succeed in this role, you should have the following skills and experience:

• Preferred bachelor's degree in relevant discipline.
• Experience managing a software sales funnel and prioritizing opportunities requiring escalation or acceleration to ultimately deliver on results
• Deep customer-orientation, track record of ability to cultivate strong customer relationships with key decision makers (incl. C-suite)
• Understand how to efficiently leverage specialist knowledge / product resources to develop tailored customer offerings
• Resilient sales mindset able to adapt in a dynamic customer environment
• Proven track record of creating and executing account plans towards sales objectives and delivering commercial targets
• Preferred in-depth experience of selling Healthcare IT products in a clinical environment, and/or great knowledge of hospital ecosystem.
• Able to clearly articulate the value of technical software and/or medical products to a range of customer profiles
• Familiarity with CRM software (Salesforce)
• Quality first and Patient Safety mindset
• Excellent verbal and written communication skills

Onsite roles require full-time presence in the company’s facilities.Indicate if this role is an office/field/onsite role.
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Your role:

• Lead DevOps strategy and execution for microservices-based applications built with ASP.NET and .NET Core.

• Design and maintain CI/CD pipelines using Azure DevOps and GitHub Actions for efficient and reliable delivery.

• Ensure seamless containerization and deployment of services using Docker and Kubernetes in AWS .

• Implement and manage Infrastructure as Code (IaC) for consistent and scalable infrastructure provisioning.

• Optimize performance and deployment strategies for GraphQL APIs within distributed architectures.

• Collaborate with architects and development teams to design scalable microservices and deployment models.

• Enforce automated testing strategies, leveraging tools like Selenium and other testing frameworks to ensure application quality.

• Drive monitoring and observability practices , leveraging tools to track health, performance, and reliability of microservices in production.

• Promote DevOps and Agile/SAFe best practices across teams, and support agile release trains (ARTs) with deployment readiness and automation.

• Provide technical mentorship , promote knowledge sharing, and guide junior team members in DevOps practices.

• Contribute to incident response, postmortems, and continuous improvement efforts for production environments.

You're the right fit if:

• Bachelor's or Master’s in Computer Science, Engineering, or related discipline.

• Proven experience implementing DevOps for microservices architectures at scale.

• Strong hands-on expertise in AWS & Azure cloud services and managing microservices applications on AWS EKS

• Proficient in ASP.NET, .NET Core , and deployment practices for distributed systems.

• In-depth knowledge of GraphQL API design and performance optimization.

• Expertise in Docker, Kubernetes , and managing containerized workloads.

• Experience with Azure DevOps , GitHub , and GitHub Actions for CI/CD, release pipelines, and automation workflows.

• Familiar with automated testing methodologies and integration into CI/CD pipelines.

• Understanding of SAFe (Scaled Agile Framework) or experience in scaling agile practices.

• Experience with monitoring and logging tools for distributed systems (e.g., Application Insights, Grafana, Prometheus, ELK).

• Experience implementing blue-green , canary , or zero-downtime deployment strategies.

• Knowledge of security and compliance requirements in cloud environments (e.g., GDPR, HIPAA).

Soft Skills

• Excellent communication skills to collaborate with cross-functional teams and stakeholders.

• Strong problem-solving skills to troubleshoot issues in complex, distributed environments.

• Demonstrated leadership and mentoring abilities to guide DevOps adoption and maturity.

• High adaptability to evolving technologies, tools, and project requirements.

• Sound understanding of project management and aligning DevOps deliverables with overall business goals.

.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about .
• Discover .
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .

Sr. Regulatory Affairs Specialist

• Implements global regulatory strategies and roadmaps by leveraging a comprehensive understanding of the competitive market landscape and product marketing strategy to ensure alignment with organizational objectives.
• Works under general supervision and broad guidelines, consistently exercising independent judgment on matters of significance, ensuring adherence to company policies and regulatory requirements while maintaining high standards of performance and accountability.
• Demonstrates substantial understanding of regulator's role in the Quality System with good awareness of product lines, disease states, and customers, possessing general knowledge of business developed through education or past experience.
• Resolves a wide range of moderate complexity requests in creative ways, leads comprehensive safety risk assessments to identify potential safety incidents and regulatory non-compliance, managing these incidents in Trackwise and ensuring corrective actions are effectively implemented.
• Monitors and handles potential regulatory impacts on product safety, implementing continuous improvement processes within the regulatory framework and engaging with cross-functional teams to proactively manage regulatory risks.
• Collaborates with central and regional Regulatory Affairs teams to support establishment registration and listing, and UDI/Global Trade Identification Number (GTIN) related activities, maintaining processes for regulatory filings/ licenses and developing technical contribution.
• Coordinates and facilitates witness testing to ensure products comply with safety regulations, maintaining direct contact with certification bodies, test houses, and regulatory personnel in local sales organizations.
• Takes ownership of regulatory planning for new product introductions and product changes, assisting in the maintenance of regulatory compliance throughout the product lifecycle.
• Supports the development of the regulatory plan, offering guidance on risk assessment and necessary corrective actions to meet regulatory requirements, including product registrations such as CE Marking and clinical evaluations.
• Develops and facilitates regulatory submissions for both new and existing products/solutions, ensuring accuracy and completeness to expedite regulatory approval processes effectively, preparing regulatory justifications to support submission filing decisions.
• Creates, reviews, and validates marketing and labeling materials, providing support to projects and other key regulatory initiatives while ensuring compliance with regulatory guidelines and standards.
• Recommends enhancements in systems and processes to solve problems or improve effectiveness of job area by collaborating with other functions, making periodic or ad-hoc revisions to Regulatory SOPs and templates.
• Implements safety and compliance requirements for product development projects and OEM/ODM products, communicating and integrating regulatory standards into the I&D organization through memos, training sessions, and deployment strategies.
• Administers the compliance protocol process within PDLM and MLD, overseeing safety certifications and country-specific approvals to ensure products meet international regulatory standards.(4 x bullets max)
1. Experience:- 8+years of experience in Regulatory Affairs Specialist in USFDA and EUMDR
2. Skills- Dossier Preparation, Content development, Software background will be added advantage.
3. Education.- Bachelor's / Master's Degree in any Engineering
4. Anything else.- Good communication Skills, ready to work 30% non-medical device,

Regulatory Requirements
• Document Auditing
• Data Management
• Regulatory Reporting
• Product Registrations
• Product Labeling
• Strategy Implementation
• Stakeholder Management
• Regulatory Submission Documentation
• Conformity Assessment
• Regulatory Intelligence
• Regulatory Compliance
• Risk Mitigation Strategies
• Continuous Improvement
• Project Management

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about .
• Discover .
• Learn more about .
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care .

Your role:

• Participates in full software development processes, working with broader autonomy and in pairing mode with other software team members, challenging requirements, design, and quality.

•Full Stack Development: Participate in the entire software development lifecycle, from conceptualization and design to implementation, testing, deployment, and ongoing support.

Back-End Development (Dual Expertise):
Go (Golang): Design, develop, and maintain high-performance and scalable back-end services, APIs, and microservices using Go. Leverage Go's concurrency features and standard library effectively.

Front-End Development: Develop and maintain engaging and responsive user interfaces using modern JavaScript frameworks (e.g., React, Angular, Vue.js), HTML, and CSS. Ensure seamless integration with both Go and .NET back-end services.

Database Management: Design and implement efficient database schemas and interact with various database systems relevant to both Go and .NET applications (e.g., PostgreSQL, MySQL, SQL Server, MongoDB, Redis). Optimize database queries for performance.

API Design and Integration: Design and implement RESTful or GraphQL APIs that cater to the needs of both Go and .NET based applications. Integrate with internal and external services.

Testing: Write comprehensive unit, integration, and end-to-end tests to ensure the reliability and quality of the software developed in both Go and .NET.

Continuous Learning: Stay abreast of the latest developments and best practices in both the Go and .NET ecosystems, as well as front-end technologies.

• Takes on moderately complex software development tasks, collaborating with senior team members to deliver high-quality software solutions that meet project requirements.

• Develops and executes comprehensive test plans, including unit, integration, and system tests, to ensure software reliability, performance, and adherence to specifications.

• Conducts thorough code reviews to ensure adherence to coding standards, identify potential bugs, and promote best practices in software development, fostering a culture of continuous improvement and high-quality code.

• Supports DevOps in deploying software, setting, monitoring, and ensuring own performance metrics are met, while also defining, monitoring, and meeting broader performance and quality metrics.

• Diagnoses and resolves software defects by analyzing logs, reproducing issues, and implementing effective fixes to enhance software reliability and performance.

• Creates and maintains comprehensive technical documentation, including system architecture diagrams, API specifications, and user guides to facilitate knowledge sharing and support.

• Keeps abreast of emerging technologies, industry trends, and best practices in software development to continuously improve skill sets and apply innovative solutions.

• Applies analytical skills to resolve medium complexity requests efficiently, exercising judgment within defined procedures/practices to determine appropriate action.

You are fit if:

• 4+ years of experience as a Full Stack Developer with Golang & .Net participate in the entire software development lifecycle, from conceptualization and design to implementation, testing, deployment, and ongoing support.
• Bachelor's degree in computer science, Software Engineering, Information Technology OR Vocational Education in Information Technology or equivalent.
• Master's degree in information technology, Computer Science, Software Engineering or equivalent is preferred.

• Technical Documentation
• Software Test Automation
• Agile Methodology
• Software Development Life Cycle (SDLC)
• Business Acumen
• Continuous Improvement
• Version Control System
• Quality Specifications
• Software Design
• Code Reviews
• Programming Languages .NEt, GO lang,Python, Powershell, SQl
• Debugging
• API Design
• API Integration
• Test Driven Development (TDD)

Onsite roles require full-time presence in the company’s facilities.

This role is an office-based role.

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