Senior Regulatory Affairs Specialist

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. GenDx, part of the Eurobio Scientific Group since 2022, is headquartered at Utrecht Science Park in The Netherlands. The current vacancy is for a position at our site in Stockholm, Sweden. 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 Senior Regulatory Affairs Specialist. In this role, you will lead RA activities, ensuring regulatory compliance across products and documentation. Responsibilities

• Act as a team lead for the Regulatory Affairs function, providing technical guidance, coordinating regulatory activities, and managing priorities in collaboration with the Director Compliance.
• Prepare, review and/or approve regulatory Technical Documentation.
• Monitor new regulatory and legal requirements to ensure compliance for commercially available products and products under development.
• Review and approve Marketing Material to ensure regulatory compliance.
• Contribute to internal and external audits and audit readiness.
• Provide regulatory guidance and training to internal teams.

Requirements

• Education: Bachelor’s degree or higher in Biomedical Science, Life Sciences, Engineering, Biotechnology, or a related field.
• Work experience: Minimum 4 years of experience in Regulatory Affairs within a regulated medical device, IVD, pharmaceutical, or similar environment.
• A proactive, independent and structured approach to work, with strong analytical and project management skills.
• A keen eye for detail and a strong sense of quality.
• A collaborative and communicative mindset, with the confidence to work effectively with colleagues and external partners.
• Fluent in written and spoken English.
• Eligible to live and work in Sweden.
• Residing at a commutable distance from the office.

What we offer

• A full-time position (40 hours/week).
• A permanent contract.
• An on-site position at our location in Stockholm, Sweden.
• Access to Employee Assistance Program ‘OpenUp’.

Ready to make a real-world impact? At GenDx, you are part of a motivated team with one mission: to contribute to the quality of life and survival chances of transplant patients. We are looking forward to hear what you could bring to our team! Apply now via the button below. Information For more information you can contact Maria Ilar (Director Compliance) at m.ilar@gendx.com or +4670 152 29 79. If you would like to apply at GenDx, we kindly ask you to contact our HR team directly To be considered for this position, you must be legally permitted to live and work in the Netherlands. We will take all steps reasonably necessary to ensure that your data is treated securely, and confidentially, in accordance with the GenDx Recruitment Privacy Policy. GenDx does not consider unsolicited resumes from any third-party recruiters/agencies.