Regulatory Affairs Officer

Vacature

To strengthen our team, we offer a challenging position for an accurate and dedicated Regulatory Affairs Officer to support the development of new products from early on, ensuring compliance with regulatory requirements.

As Regulatory Affairs Officer at GenDx, you collaborate with other teams in preparing and submitting technical dossiers to ensure that new products are in accordance with regulatory requirements.

Responsibilities

• Support the regulatory guidance regarding development, evaluation, and/or marketing of current and new products.
• Interpretation and implementation of regulatory requirements to newly developed products.
• Ensure accuracy and compliance with regulatory standards.
• Collaborate with Regulatory Authorities.
• Support and monitor the implementation of complaint processing systems.
• Support activities such as audits and/or product recalls.
• Work according to ISO 13485 standards.

Profiel

To succeed in this role

• PhD in molecular biology (or equivalent) or acquired level through working experience.
• Between 2- 5 years of experience in regulatory affairs (preferably IVD related).
• Analytical skills.
• Effective in communication.
• Outstanding in keeping overview with attention to detail.
• Comprehensive workstyle.
• Excellent command of Dutch and English (written and spoken).
• You live, or are willing to relocate, near Utrecht Science Park.

Arbeidsvoorwaarden

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 healthy lunch.
• Competitive salary.
• Pension scheme.
• Compensation for commuting traffic.
• Employment based on a 40 hour work week.
• Option to work part-time (minimum 80%).
• Laptop.
• 25 holidays and a week paid Christmas leave.
• Sport pass for Sports Center Olympos.

Bedrijfsprofiel

GenDx, experts in transplant 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 Chimerism monitoring 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 based at Utrecht Science Park in The Netherlands, and we have an office in Chicago, IL, USA. Since 2022, GenDx is 100% owned by French entity Eurobio Scientific SA.

With a highly educated and motivated team of about 100 colleagues, we contribute to the quality of life of transplant patients.

Contact

Information
For more information you can contact Erica Kremer, Director Compliance +31 6 225 259 48.

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? Apply now and maybe you will soon be part of the GenDx team. Send your CV and motivation to our HR Team, hrm@gendx.com. Please mention ‘2024_08_RAO’ and your name in the e-mail subject line.

Unsolicited third party/agency profiles and resumes will not be considered.