Hilda Njock
@hildanjock
Medical device safety and pharmacovigilance specialist driving compliance and risk management across product lifecycles.
BelgiumWhat I'm looking for
I am a Medical Device Safety & Pharmacovigilance Specialist with over five years' experience managing safety activities for integral and non-integral devices, in vitro diagnostics, and SaMD. I lead cross-functional teams to ensure regulatory compliance from design through post-market surveillance.
I have a proven record creating and optimizing SOPs and workflows, maintaining safety documentation, and delivering regulatory reporting aligned with MDR, ISO 14155, FDA 21 CFR, and ICH-GCP. I maintain safety performance metrics and use safety database systems such as Argus, RMP, and iMedidata to support timely decision-making.
I communicate fluently in English, Dutch, French, and German and collaborate with internal and external stakeholders to balance priorities while ensuring accurate safety case processing, narrative writing, and regulatory submissions.
Experience
Work history, roles, and key accomplishments
Led safety activities for pharmaceutical and device-related clinical research, processing adverse events, writing narratives, and submitting regulatory reports while implementing safety management plans aligned with MDR and ISO 14155.
Documented and responded to safety inquiries and generated adverse event and product quality complaint reports using precise medical terminology and approved resources.
Marketing Communications Manager
Klugcode Technologies Ltd
Jan 2020 - Jan 2021 (1 year)
Managed cross-country communications and market data analysis and collaborated with IT and legal teams to produce compliant promotional materials.
Student Marketer
Novosanis Medical Devices
Jul 2020 - Dec 2020 (5 months)
Managed literature and ethics documentation, ensured GDPR compliance, and maintained accurate protocol updates for medical device studies.
Education
Degrees, certifications, and relevant coursework
Deggendorf University of Applied Sciences
Master of Science, Digital Health
2023 -
Master of Science in Digital Health focusing on digital health technologies and their application in clinical and regulatory contexts.
Deggendorf University of Applied Sciences
Bachelor of Science, Health Informatics
2019 - 2023
Bachelor of Science in Health Informatics covering health IT, clinical data management, and digital health systems.
UC Leuven-Limburg (University College Leuven-Limburg)
Professional Bachelor (Foundation Year), Chemistry
2018 - 2019
Professional Bachelor's foundation year in Chemistry providing foundational chemistry and laboratory skills.
Linguapolis - University of Antwerp / ILT- KU Leuven
NT2 Advanced Diploma, Dutch Language
2017 - 2019
NT2 Advanced Dutch language diploma demonstrating advanced proficiency in Dutch for professional use.
University of Buea
Bachelor of Science, Biomedical Science
2013 - 2016
Bachelor of Science in Biomedical Science with coursework in biomedical fundamentals and laboratory techniques.
Availability
Location
BelgiumAuthorized to work in
Job categories
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