Freelance Medical Device Compliance Specialist
7 dagen geleden
As a Norm Compliance Officer for IGT Systems, you will play a crucial role in ensuring that our medical devices meet the highest standards of safety and regulatory compliance. This is a unique opportunity to join our team and contribute to the development of innovative medical solutions.
Key Responsibilities:- Develop and implement compliance strategies for IGT systems, ensuring adherence to international and national regulations, including MDR and Philips Healthcare processes.
- Collaborate with cross-functional teams to develop and execute standards and compliance plans, ensuring seamless integration with product development.
- Define and implement standards and regulations for products, including IEC 60601 series, IEC 62304, and EU MDR.
- Secure implementation and verification of legal requirements, reviewing project deliverables to ensure compliance.
- Support designers and testers in interpreting and testing standards and regulations, ensuring technical design meets regulatory requirements.
- Arrange and complete evidence for product certification by independent certifying agencies.
- Provide technical support to the Regulatory Affairs department, preparing submissions to regulatory bodies and countries.
- Bachelor's degree or higher in a technical field, health sciences, or related.
- At least 3-5 years of experience in software and/or hardware testing/engineering or similar roles in a complex environment.
- Background in the global medical devices industry is a strong plus.
- Knowledge of product safety standards, such as IEC, is preferred.
- Familiarity with national and international regulations is an advantage.
- Well-developed project management skills are preferred.
- Proven experience in improvement activities and audits is an advantage.
- IEC series, including collateral- and X-ray related particular standards.
- IEC 62304 and IEC 62366-1.
- EU MDR and 21 CFR 820.
- Artificial intelligence-related standards and regulations.
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Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will play a crucial role in ensuring that our medical devices meet the highest standards of safety and regulatory compliance. This is a unique opportunity to join our team and contribute to the development of innovative medical solutions.Key Responsibilities:Develop and...
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Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will play a crucial role in ensuring that our medical devices meet the highest standards of safety and regulatory compliance. This is a unique opportunity to join our team and contribute to the development of innovative medical solutions.Key Responsibilities:Develop and...
-
Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will play a crucial role in ensuring that our medical devices meet the highest standards of safety and regulatory compliance. This is a unique opportunity to join our team and contribute to the development of innovative medical solutions.Key Responsibilities:Develop and...
-
Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will play a crucial role in ensuring that our medical devices meet the highest standards of safety and regulatory compliance. This is a unique opportunity to join our team and contribute to the development of innovative medical solutions.Key Responsibilities:Develop and...
-
Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will play a crucial role in ensuring that our medical devices meet the highest standards of safety and regulatory compliance. This is a unique opportunity to join our team and contribute to the development of innovative medical solutions.Key Responsibilities:Develop and...
-
Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will play a crucial role in ensuring that our medical devices meet the highest standards of safety and regulatory compliance. This is an exciting opportunity to join our team and contribute to the development of innovative medical solutions.Key Responsibilities:Define and...
-
Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will play a crucial role in ensuring that our medical devices meet the highest standards of safety and regulatory compliance. This is a unique opportunity to join our team and contribute to the development of innovative medical solutions.Key Responsibilities:Define and...
-
Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will play a crucial role in ensuring that our medical devices meet the highest standards of safety and regulatory compliance. This is a unique opportunity to join our team and contribute to the development of innovative medical solutions.Key Responsibilities:Define and...
-
Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will play a crucial role in ensuring that our medical devices meet the highest standards of safety and regulatory compliance. This is a unique opportunity to join our team and contribute to the development of innovative medical solutions.Key Responsibilities:Develop and...
-
Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will play a crucial role in ensuring that our medical devices meet the highest standards of safety and regulatory compliance. This is a unique opportunity to join our team and contribute to the development of innovative medical solutions.Key Responsibilities:Develop and...
-
Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will play a crucial role in ensuring that our medical devices meet the highest standards of safety and regulatory compliance. This is a unique opportunity to join our team and contribute to the development of innovative medical solutions.Key Responsibilities:Define and...
-
Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will play a crucial role in ensuring that our medical devices meet the highest standards of safety and regulatory compliance. This is a unique opportunity to join our team and contribute to the development of innovative medical solutions.Key Responsibilities:Define and...
-
Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will play a crucial role in ensuring that our medical devices meet the highest standards of safety and regulatory compliance. This is an exciting opportunity to join our team and contribute to the development of innovative medical solutions.Key Responsibilities:Define and...
-
Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will play a crucial role in ensuring that our medical devices meet the highest standards of safety and regulatory compliance. This is a unique opportunity to join our team and contribute to the development of innovative medical solutions.Key Responsibilities:Define and...
-
Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will play a crucial role in ensuring that our medical devices meet the highest standards of safety and regulatory compliance. This is a unique opportunity to join our team and contribute to the development of innovative medical solutions.Key Responsibilities:Define and...
-
Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will be part of a dynamic team responsible for ensuring the company's products comply with international and national regulations, including MDR and Philips Healthcare processes.Key Responsibilities:Define applicable standards and regulations for products to be developed,...
-
Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will be part of a dynamic team responsible for ensuring the company's products comply with international and national regulations, including MDR and Philips Healthcare processes.Key Responsibilities:Develop and implement standards and compliance plans for IGT systemsDefine...
-
Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will be part of a dynamic team responsible for ensuring the company's products comply with international and national regulations, including MDR and Philips Healthcare processes.Key Responsibilities:Develop and implement standards and compliance plans for IGT systemsDefine...
-
Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will be part of a dynamic team responsible for ensuring the company's products comply with international and national regulations, including MDR and Philips Healthcare processes.Key Responsibilities:Develop and implement standards and compliance plans for IGT systemsDefine...
-
Freelance Medical Device Compliance Specialist
7 dagen geleden
De Mortel, Nederland Yacht VoltijdNorm Compliance Officer IGT SystemsAs a Norm Compliance Officer for IGT Systems, you will be part of a dynamic team responsible for ensuring the company's products comply with international and national regulations, including MDR and Philips Healthcare processes.Key Responsibilities:Define applicable standards and regulations for products, such as IEC 60601...
