Norm Compliance Officer IGT Systems

Randstad Professional | Yacht

Regulatory Compliance Officer - IGT Systems
(We are looking for candidates who are currently based in the Netherlands)
Start Date:ASAP
Duration of the contract: 1 year
Location:Eindhoven

Support the Norm Compliance team's efforts and deliverables for IGT-systems that adhere to all applicable national and international laws, including Philips Healthcare procedures and MDR.

Develop and implement the standards and compliance plan while serving as a representative of the Norm Compliance team in a cross-functional development team.

Working at Philips will allow you to contribute to advanced health technology and solutions that enhance the lives of billions of people worldwide and work on initiatives that will change lives.

Functie-eisen

- Identifying relevant standards and laws (e.g., EU MDR, IEC 60601, IEC 62304, IEC 62366-1) to design products.
- Defining the plan to incorporate rules and guidelines for demonstrating compliance
- Creating deliverables for norm compliance and ensuring the implementation and verification of legal requirements.
-Assisting testers and designers in interpreting and evaluating rules and guidelines pertaining to the technical design of IGT products
-Assembling and finishing the documentation required for the independent certifying body to certify the product
-Providing technical support to the Regulatory Affairs division for preparing submissions to regulatory bodies and authorities.

Preferred knowledge in the following medical domain standards:

• IEC 60601-1 series, including collateral and X-ray-related standards.
• IEC 62304 and IEC 62366-1.
• EU MDR and 21 CFR 820.
• AI related standards and regulations.

Competenties

You bring with you the following skills set:

• A bachelor’s degree in a technical field, health sciences, or related
• 3-5 years of experience in software and/or hardware testing/engineering, or in similar roles within a complex environment.
• Experience in the international medical device sector is a significant advantage.
• Familiarity with product safety regulations, such as IEC 60601, is beneficial.
• Knowledge of other international and national regulations is a plus.
• Strong project management skills are ideal.
• Proven experience with audits and improvement initiatives is beneficial.
• A team player who contributes to the success and atmosphere of the project.

Arbeidsvoorwaarden

Primary Employment Conditions:

• Competitive salary based on industry standards (considering degree and experience).
• 13th month salary (paid periodically, pro-rata).
• 8.33% holiday pay, calculated on a 12-month salary.

Secondary Employment Conditions:

• Pension Plus scheme (starting from day 1).
• €750 net allowance for setting up your home workplace.
• 13th month salary (paid periodically on a pro-rata basis) or the option for a quarterly bonus (4-8%, averaging 1 month's salary annually).
• 25 vacation days per year (based on a 40-hour work week).
• Travel expenses reimbursement.
• Yacht Academy with an annual training budget of up to €3,500.
• Referral bonuses up to €1,500.

Bedrijfsinformatie

Philips is a global leader in health technology, committed to improving people's lives through meaningful innovation. With a strong focus on enhancing patient outcomes and advancing healthcare systems, Philips provides a wide range of solutions spanning medical devices, diagnostics, and digital health. The company is dedicated to delivering high-quality, sustainable products that drive improvements in both clinical and personal healthcare environments. By combining cutting-edge technology with a deep understanding of customer needs, Philips continues to make a positive impact on global health and well-being.
 

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