Regulatory Affairs Engineer

• HBO+/university level working/thinking; with a degree at the intersection of technology, production processes, and human interaction, such as: Biomedical Engineering, Industrial Engineering & Management, Industrial Engineering, Technology Management, etc.

• Knowledge of relevant standards, laws, and regulations such as ISO 13485, QMSR, ISO 9001, AS9100;

• Experience with interpreting and applying standards and norms;

• Is analytically strong, communicates clearly and persuasively, and works thoroughly and decisively based on facts and objective analyses.

• Preferably familiar with the role of a contract designer/manufacturer within a supply chain.

• A fine salary range from €4,159 to €7,010 gross per month on a full-time basis, depending on your previous (consecutive) work experience.

• Variable, turnover-dependent, quarterly bonus that can amount to a maximum of 5% of your quarterly salary.

• Enjoy 40 days off per year (27 vacation days and 13 ATV days).

• Room for growth and development opportunities, for example to progress in your career or to broaden your knowledge with one of the many training opportunities via the Benchmark Academy.

• Flexible working hours. As long as you take responsibility for completing your work, we offer you the possibility to schedule your working hours flexibly and align them with the lifestyle that suits you.

• Participation in our BE-Fit program, exercising with colleagues at the expense of Benchmark. Together we have already kickboxed, done cross-fit, and attended padel clinics.

You are the conscience behind technology that matters.

Whether it concerns in-vitro diagnostic systems (IVD), life-sustaining devices, or complex high-tech applications within the defense and semiconductor industries: you ensure that products demonstrably comply with laws and regulations, standards, and customer requirements throughout their entire lifecycle. You monitor compliance, manage risks, and make it possible for products to be developed, produced, and applied safely, reliably, and successfully.

As a Regulatory Affairs Engineer, you translate complex regulations into clear choices for project teams and customers. You assess risks, determine the regulatory strategy, and ensure the correct substantiation is present to register, release, and keep products compliant worldwide.

Thanks to your expertise, innovative products can be deployed safely and compliantly in environments where reliability is not an option, but an absolute requirement.

• Translating regulations and customer requirements into actionable product and quality requirements.

• Determining and monitoring the regulatory strategy within development and change processes.

• Advising customers and project teams on compliance, risks, and market authorization.

• Reviewing and releasing critical technical and quality documentation.

• Performing impact analyses for design, process, and documentation changes.

• Approving validations, qualifications, and release activities.

• Supporting product introductions throughout the entire product lifecycle.

• Representing Benchmark during audits, customer reviews, and certification processes.

• Initiating improvements to strengthen compliance and product quality.

This role emphatically does not take place solely behind a desk. You work daily with customers, project teams, engineering, operations, and quality. From the first customer inquiry to validation, production introduction, and volume production, you are an important sparring partner and decision-maker.

With this, you have a direct influence on product quality and user safety, customer satisfaction, and the success of new technologies in the market.

Additionally, you get the unique opportunity to actively contribute to the further professionalization and development of Regulatory Affairs within Benchmark. You will help build the processes, working methods, and expertise that are decisive for the future growth of our medical and high-tech activities.

You are the conscience of Benchmark! You ensure that innovation complies, performs, and reaches the market.