The Senior Regulatory Affairs Specialist is responsible for ensuring regulatory compliance to applicable standards and regulations and collaborates closely with the Product Development teams for the preparation and submission of Technical documentation (EU MDR and FDA).
• Work with other departments and communicate the requirements needed to prepare technical documentation in compliance with country specific regulations.
• Create templates for Technical Documentation Index in compliance with applicable regulations.
• Support for preparation and submission of technical documentation (EU MDR and FDA).
• Review and create product labels and review promotional materials for compliance with applicable regulations and technical standards.
• Own Applicable Standards List and conduct assessment for compliance and guide product development team for implementation.
• Support for risk management activities.
• Responsible for implementing UDI registration and assignment to products.
• Maintain regulatory registrations such as GUDID/EUDAMED & WEEE compliance.
• Assist in preparing response to regulatory authorities' questions within assigned timelines.
• Keep up to date with changes in regulatory legislation and guidelines and conduct impact assessment.
• Perform other related duties and responsibilities as assigned.
• Masters’ degree or equivalent with a specialization in Regulatory.
• At least 5 years of experience in Medical Device regulatory. Experience with active implantable devices is a plus.
• Familiar with the use of quality management system (ISO 13485), and other horizontal standards such as ISO 62304, IEC 60601, ISO 62366, ISO 15223-1.
• Understanding of Regulatory processes in MedTech: Medical Device Regulation, FDA regulatory pathway.
• Experience with technical document preparation for Medical Devices, in particular risk management ISO 14971, GSPR checklist.
• Experience with UDI implementation and assignment.
• A high energy, self-motivated, pro-active personality able to work in a diverse team within a start-up company; willing to help colleagues.
• Results oriented, hands-on and thrives well in an innovative, fast-paced and performance driven organization.
• Strong oral and written English language proficiency. Mastering of French and/or Dutch language is highly appreciated.
• Represents the ONWARD CODE (values).
Do you want to join our team as our new Senior Regulatory Affairs Specialist? Then we'd love to hear about you!