Product Risk Manager
3 weeks ago
Job title: Product Risk Manager
Job Description
- The Risk Manager is responsible for 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.
Minimum Required Skills And Knowledge
- Bachelor's degree in Healthcare, Science or Engineering with several years of related experience
- Minimum 10-12 years 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
- 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
- Proficient in utilizing business tools such as: Outlook, Microsoft
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.
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