Freelance Medical Device Compliance Specialist

7 dagen geleden


De Mortel, Nederland Yacht Voltijd
Norm Compliance Officer IGT Systems

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:
  • Define and implement standards and regulations for IGT systems, including MDR and Philips Healthcare processes.
  • Develop and execute the standards and compliance plan, collaborating with cross-functional teams.
  • Secure the implementation and verification of legal requirements, reviewing project deliverables and providing technical support to designers and testers.
  • Arrange and complete evidence for product certification by independent certifying agencies.
  • Provide regulatory affairs support, preparing submissions to regulatory bodies and countries.
Requirements:
  • 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 and experience in improvement activities and audits are desirable.
Preferred Standards and Regulations:
  • 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.


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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,...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...


  • De Mortel, Nederland Yacht Voltijd

    Norm 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...