Regulatory Affairs Associate

GenDX Products Inc.; Utrecht; Híbrido; EUR 52.000 - 76.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Generous holidays

Partial‑time option 0.8 FTE

Commuting allowance

Laptop

Sport pass

Employee Assistance Program

Office lunch facilities

Descripción de la vacante

GenDx is looking for a Regulatory Affairs Associate to join our Utrecht team, developing products from early stages and ensuring regulatory compliance. You will help integrate regulatory requirements into product development and support submissions to authorities.

Ideal candidates have a science background (BSc/MSc) and experience in biotech/IVD, with strong English writing and communication skills. This is a full-time role at the Utrecht Science Park site in the Netherlands.

Formación

• Education: BSc or MSc in molecular biology, life sciences or equivalent.
• Writing: translate regulatory or scientific info into clear documentation.
• Communication: collaborate with colleagues across disciplines and external stakeholders.
• Analytical: assess regulatory requirements and impact on products/processes.
• English: excellent written and spoken English.

Responsabilidades

• Provide regulatory guidance throughout development, evaluation, and marketing of current and new products.
• Interpret and translate regulatory requirements into practical product development needs.
• Support preparation, review and maintenance of regulatory documentation and dossiers.
• Ensure accuracy and compliance of the QMS.
• Communicate with regulatory authorities and notified bodies.
• Support audits, recalls and post‑market activities.

Conocimientos

Writing skills

Communication

Analytical skills

Educación

BSc/MSc in molecular biology or life sciences

Descripción del empleo

GenDx, where innovation drives diagnostics
GenDx is a global leader in molecular diagnostic laboratory solutions for high resolution tissue typing of both donors and patients and monitoring transplant success. We combine our cutting‑edge software solutions, reagents for DNA sequencing‑based HLA typing and transplant surveillance strategies with our excellent customer support including a comprehensive education program. Our products are sold all over the world through direct sales and distributors.

The GenDx office is headquartered at Utrecht Science Park in The Netherlands. Since 2022, GenDx is part of the Eurobio Scientific Group, headquartered in Les Ulis, France.

With a highly motivated and educated team of over 200 colleagues, we contribute to the quality of life and survival chances of transplant patients. Do you want to be part of an innovative company that offers ample time for development?To strengthen our team, we offer a challenging position for an accurate and dedicated Regulatory Affairs Associatewho enjoys working at the intersection of science, product development, and regulatory requirements

As Regulatory Affairs Associate at GenDx, you will be involved in the development of new products from an early stage. You will help integrate regulatory requirements into product development and support the preparation and submission of technical documentation to the relevant regulatory authorities. In this role, you will work closely with colleagues across different teams to ensure that our products meet applicable regulatory requirements.

Responsibilities

• Provide regulatory guidance and support throughout the development, evaluation, and marketing of current and new products.
• Interpret and translate regulatory requirements into practical requirements for newly developed products.
• Support the preparation, review, and maintenance of regulatory documentation and technical dossiers.
• Ensure the accuracy, completeness, and compliance of the QMS.
• Communicate and collaborate with relevant regulatory authorities and notified bodies.
• Support quality and regulatory activities related to audits, product recalls, and other post‑market activities.
• Work in accordance with applicable regulations (e.g. IVDR) and ISO 13485 standards.

Requirements

• Education: BSc or MSc in molecular biology, Life Sciences or equivalent.
• Work experience: Relevant professional experience, ideally within a biotech, medical device, or IVD environment, is an advantage.
• Writing skills: You have an affinity for writing and are able to translate complex regulatory or scientific information into clear, structured documentation.
• Communication: You are comfortable working with colleagues from different disciplines and communicating with external stakeholders.
• Analytical skills: You work accurately and systematically and are able to assess regulatory requirements and their impact on products and processes.
• Language: Excellent command of English, both written and spoken.
• Location: You currently live within a reasonable commuting distance of Utrecht Science Park or are willing to relocate.
• To be considered for this position, you must be legally permitted to live and work in the Netherlands. Sponsorship for a work visa may not always be possible.

Preferred skills

Bringing one or more of these is an advantage, but if you have not mastered these skills yet, we still encourage you to apply.

• Knowledge of IVD and/or medical device regulations, preferably the EU IVDR.
• Familiarity with ISO 13485 and quality management systems.
• Experience with technical documentation and/or regulatory submissions.
• Ability to interpret regulatory requirements and translate them into practical requirements for product development.
• Familiarity with CAPA, change control, and risk management.

What do we offer

• A team of like‑minded people who all strive to deliver the highest quality products possible.
• An international working environment.
• New office facilities accommodating the GenDx café to enjoy your daily, freshly prepared lunch.
• 25 holidays and a week paid Christmas leave.
• Compensation for commuting traffic.
• Full‑time contract of 40 hours/week (1.0 FTE).
• Option to work part‑time (0.8 FTE minimum).
• Sport pass for Sports Center Olympos.
• Employee Assistance Program (OpenUp).
• Laptop.

Information

For more information you can contact Eike Schwindt, RA Manager, at [phone].

Do we match?

Join the experts in transplant diagnostics! Do you want to be part of an innovative company that offers excellent working conditions and ample time for personal development? Maybe you will soon be part of the GenDx team.

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