Respironics Inc
Location
Bangalore | India
Job description
Job title: Product Safety Risk Manager
In this role, you have the opportunity to
The Risk Manager will assume a crucial role in safeguarding the Quality, Safety, and compliance of Philips' Radiology Informatics software medical devices. This involves leading, executing, coordinating, and monitoring activities related to product safety risk management throughout the entire product lifecycle. The Risk Manager is integral to ensuring the safety, efficacy, and overall quality of Radiology Informatics.
You are responsible for
. Ensures the Policy for Establishing Safety Risk Acceptability for the product is created, approved, and maintained by top management.
. Ensures product safety risk management deliverables are created, maintained, and stored in the Risk Management file during product development.
. Monitors and reports on the product's safety risk management performance in the field and ensures deliverables are updated as needed. Ensures the appropriate risk assessments are performed when triggers are met.
. Represent Risk Management and design quality activities during external and internal audits.
. Perform periodic reviews of Risk Management Files and ensure those are performed according to schedule.
. Monitor post product data (e.g. Complaints, Corrective and Preventive Actions (CAPA), Non-conformance Reports (NCRs), Customer Feedback information, etc.) for impact to the Risk Management Files.
. Coordinates with a cross functional team including Engineering and Medical Affairs in the creation and maintenance of the deliverables listed above.
You are a part of
You are part of a dynamic team that develops software as a medical device, this role is an integral part of the Quality organization under the Radiology Informatics Business Unit.
To succeed in this role, you should have the following skills and experience
. Bachelor's degree, Engineering or Science discipline preferred or equivalent work experience
. 5+ years working experience in a regulated industry specially software as a medical device.
. 5+ years working experience in product development or post-market surveillance, system engineering experience.
. Experience in creating risk management deliverables.
. Knowledge of ISO14971 and product specific regulations and standards.
. Clinical knowledge highly desired.
. Ability to work with multisite teams.
. Proactive and self-driven.
About Philips
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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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:
There's a certain energy when everyone's in the same room that can heighten idea generation and creative friction needed for problem-solving.
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.
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.
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