Location
Pune | India
Job description
Job Description
Job Description
You are responsible for
- Ensures product safety risk management deliverables are created, maintained, and stored in the Risk Management file during product development and during lifecycle management of product per ISO 14971 and product specific regulations and standards.
- Monitors and reports on the product safety risk management performance in the field and ensures deliverables are updated as needed.
- Ensures the appropriate risk assessments are performed per risk management procedures.
- Defend 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.
- Evaluate process and product changes for their impact to the current Risk Management Files.
- 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
- Work with global experts to drive the common practice and best practice across sites for risk management, design regulations compliance and business requirements
- Coordinates with a cross functional team including Engineering and Medical Affairs in the creation and maintenance of the deliverables listed above
- Makes a fundamental contribution to the innovation of products or processes.
- Solves fundamental problems on the basis of thorough (unique) knowledge in the professional field.
- Solves technical problems that have never been encountered previously in the organization.
- Generates initiatives with regard to technological improvements and performs future-oriented studies in dialogue with other specialists.
- Makes substantial contribution to the innovation process and communicates new insights to own business.
You are a part of
DXR R&D group which is a global organization organized by product tiersu00A0 & platforms. Each product tier is composed of various products & solutions.
To succeed in this role, youu2019ll need a customer-first attitude and the following
- BTECH/ MTECH in Electrical/Mechanical/Software engineering/Physics/other relevant degree.
- At least 7 years of experience as a Risk Manager [3+ years working experience in product development or post-market surveillance, system engineering experience]
- Knowledge and understanding of regulations related to risk management and the development of safe hardware and software products including ISO14971, FDA Regulations 21CFR 820, EU MDR, IEC 60601-1, IEC 62304, and IEC 62366-1.
- Participates in regulatory inspections and notified body audits.
- Risk Analysis Methodology know-how (e.g., FMEA, FTA, PHA)
- Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-functional teams.
- Excellent interpersonal skills and the ability to influence
- Experience in creating risk management deliverables
- Knowledge of ISO 14971 and product specific regulations and standards
- Clinical knowledge an advantage
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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If youu2019re 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 commitment to diversity and inclusion .
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