Norm Compliance Officer

3 maanden geleden

Best, Nederland amaris Voltijd

Job description
**In this role, you will have the opportunity to**:
Be part of the Norm Compliance team, ensuring alignment with all relevant international and national regulations, including MDR and internal healthcare processes.
Participate in a cross-functional development team, representing the Norm Compliance function, and contribute to the development and execution of the standards and compliance plan.
**You are responsible for**:
Defining the applicable standards and regulations for products under development, such as IEC 60601 series, IEC 62304, IEC 62366-1, EU MDR, among others.
Outlining how required standards and regulations will be addressed within the Standards and Compliance plan to demonstrate compliance.
Creating and managing project deliverables related to Norm Compliance responsibilities.
Ensuring the implementation and verification of all specified legal requirements by reviewing relevant project deliverables.
Supporting designers and testers in interpreting and testing standards and regulations concerning the technical design of IGT products.
Organizing and completing all necessary evidence to obtain product certification from independent certifying agencies.
Providing technical support to the Regulatory Affairs department in preparing submissions to regulatory bodies.
To succeed in this role, you should have the following skills and experience:
A bachelor’s degree or higher in a technical field, health sciences, or a related area.
At least 3-5 years of experience in software and/or hardware testing/engineering, or in a similar role within a complex environment.
Experience in the global medical devices industry is highly desirable.
Knowledge of product safety standards (e.g., IEC 60601) is preferred.
Familiarity with other national and international regulations is an advantage.
Well-developed project management skills are preferred.
Proven experience in improvement activities and audits is beneficial.
A collaborative team player who can influence the environment to achieve project success.
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade - this is made possible by an international team of 7500 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
**Brief Call**: Our process typically begins with a brief virtual/phone conversation to get to know you The objective? Learn about you, understand your motivations, and make sure we have the right job for you
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities
**Case study**: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
We look forward to meeting you

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