Philips Hiring for Norm Compliance Expert at Bengaluru, Karnataka Full Time

Job Description

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to make life better

Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

You are responsible for

Be part of the Norm Compliance team, support the Norm Compliance activities and deliverables for IGT- systems with all relevant mandatory international and national regulations including MDR and Philips Healthcare processes

Participate in a cross functional development team, representing the Norm Compliance team, develop and execute the standards and compliance plan.

You are a part of

Coordinating with vendors for outsourcing the resources for NC deliverables.

Guide & coordinate the outsourced resources to deliver the Compliance Data Records

Allocate and supervise tasks to the outsourced resources.

Review of NC deliverables

Defining, for products to be developed, the applicable standards and regulations such as e.g. IEC82304/ IEC 62304/ IEC 62366 / MDD/EU MDR/ EN 1041 / ISO 15223

Defining within the Standards and Compliance plan how the required standards and regulations will be covered into evidence for demonstrating compliance.

Ownership for the project deliverables related to Norm Compliance release evidence.

Securing the implementation and verification of all specified legal requirements by reviewing these related project deliverables

Supporting designers and testers with the interpretation and testing of standards and regulations with respect to the technical design of IGT products

Arranging and completing all evidence for gaining product certification by the independent certifying agency

Providing the Regulatory Affairs department with technical support as preparation of submission to Regulatory bodies and countries

To succeed in this role, you’ll need a customer-first attitude and the following

A Bachelor’s degree or higher in a technical field, health sciences, or related

At least 8-10 years in Software and/or hardware Testing/Engineering or experience in similar roles within a complex environment

A background in the global medical devices industry would be considered a strong plus

Knowledge of product safety standards (e.g., IEC 62304) would be preferred.

Familiarity with other national and international regulations is an advantage.

Well-developed project management skills would be preferred.

Proven experience in improvement activities and audits is an advantage.

Team player that can influence environment for project success.

In return, we offer you

Describe in two to three lines what tangible and intangible benefits the incumbent will gain in this role. Use our Employer Value Proposition (EVP) themes and information gathered in the RSM as input sources.

How we work at Philips

Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.

Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There’s a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.

We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.

We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.