Brainbox Consulting BV aligning great talent with clients’ needs is at the core of who we are. We are passionate about our Consultants, our Clients, and our Partners. Our rich IT legacy combined with our unyielding care for our people and business is the driving force behind all we do, and we deliver! On this journey, we are looking for Norm Compliance Officer who is also interested to take on a wide range of activities.

Responsibilities

• Defining, for products to be developed, the applicable standards and regulations such as e.g. IEC 60601 series, IEC 62304, IEC 62366-1, 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 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

Skills and Experience

• A bachelor’s 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
• Related to the standards in the medical domain, knowledge on the following standards is preferred:
• IEC60601-1 series including collateral- and X-ray related particular standards.
• IEC62304 and IEC62366-1
• EU MDR and 21CFR820
• Artificial intelligence related standards and regulations