Norm Compliance Officer
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Job Title
Norm Compliance OfficerJob Description
Your role:
- Defining for products to be developed the applicable standards and regulations such as e.g. IEC 60601-1 series IEC 62304 IEC 62366 and EU MDR
- Defining within the Standards and Compliance plan how the required standards and regulations will be covered into evidence for demonstrating compliance.
- Creating project deliverables related to Norm Compliance responsibilities.
- 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 Ultrasound 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
Youre the right fit if:
- A bachelors degree or higher in a technical field health sciences or related
- At least 3-5 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 60601) 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.
How we work together
We believe that we are better together than apart. For our office-based teams this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the companys facilities.
Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations.
Indicate if this role is an office/field/onsite role.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters and we wont 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.
Learn more about our business.
Discover our rich and exciting history.
Learn more about our purpose.
If youre 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 culture of impact with care here.
Required Experience:
Unclear Seniority
Key Skills
- Compliance Management
- Risk Management
- Financial Services
- PCI
- Banking
- Cost Accounting Standards
- Quality Systems
- Research Experience
- NIST Standards
- Securities Law
- SOX
- ISO 27000
About Company
Philips has been revolutionizing lighting for over 125 years. We pioneered the world changing development of electric light and LED, and are now leading the way in intelligent lighting systems. Our deep understanding of how lighting positively affects people, enables us to deliver inn ... View more
