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Product Risk Manager
Philips
posted 5hr ago
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Flexible timing
Key skills for the job
Job Description
- Managing product safety, property, and environmental risk.
- Leads Risk Management efforts, processes and process improvements for assigned product/business portfolio.
- Develops and maintains Risk Management Files that include risk management plans, hazard analyses, risk assessments and risk management matrix
- Lead issue impacts assessments to calculate risks associated with defects and complaint records
- Collaborates as risk management subject matter expert with development teams to ensure the comprehensive implementation of risk control measures are compliant to local requirements as and international standard ISO 14971
- Participates in regulatory inspection and notified body audits as risk management subject matter expert.
- Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-function teams.
You are a part of
The Design Quality Engineering Team is tasked with a dual role as an embedded member of project teams to provide expertise and guidance on the Risk Management process as it relates to our quality management system and product safety, and the role of independent oversight to ensure that Philips designs live above the common level and meet the spirit and the letter of the policies that guide product team for safe inherent design.
To succeed in this role, you should have the following skills and experience.
- Bachelor s degree in healthcare, Science or Engineering with several years of related experience
- 7-8 years working experience in a regulated industry specially software as a medical device of relevant experience in medical device risk management.
- Knowledge in ISO 13485, ISO 14971, FDA CFR 820, EU 2017/745, IEC 62304, IEC 82304 and IEC/TR 80002-1
- Medical Device Risk analysis, risk control measure evaluation, implementation and validation testing experience
- Good written and verbal communication in English language
- Strong interpersonal skills
- Knowledge and understanding of international safety standards for medical devices
- Related experience with US Class II or III (EU class IIb or III) medical devices is highly desired
- Related experience with Software as a Medical Device (SaMD), Risk analysis and Cybersecurity Risk management
Employment Type: Full Time, Permanent
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People are getting interviews through
(based on 95 Philips interviews)
Job Portal
Campus Placement
Referral
Company Website
Walkin
Recruitment Consultant
45%
15%
9%
8%
2%
2%
19% candidates got the interview through other sources.
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Confidence
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What people at Philips are saying
Product Risk Manager salary at Philips
reported by
1
employee
with 1
years exp.
₹49.4
L/yr - ₹54.6
L/yr
190%
more
than the average Product Risk Manager Salary in India
View more details
What Philips employees are saying about work life
based on 1.5k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Philips Benefits
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Philips Bangalore / Bengaluru Office Location
Bangalore Office
Philips India Limited
Philips Innovation Campus
MFAR Manyata Tech Park,
Nagavara,
Bangalore
Bangalore - 560045
Bangalore - 560045
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