Ensure product compliance with international standards, conducting quarterly
reviews and gap analyses.
? Develop, update, and maintain regulatory procedures and relevant work instructions.
? Manage and maintain EUDAMED registration and ensure compliance with EU MDR
requirements.
? Manage and maintain the Technical Documentation, ensuring it remains compliant
with applicable regulatory requirements.
? Provide regulatory assessments for design and process changes.
? Prepare and manage regulatory documentation to support global product
registrations, including submission requirements, labeling translations and
communication with Economic Operators.
? Maintain regulatory records, manage product registrations, and coordinate responses
to regulatory authorities.
Requirements: achelors degree in Biomedical Engineering, Biotechnology, or a related field.
At least three years of experience in regulatory affairs within a medical device
company.
Strong knowledge of CE marking and global regulatory requirements.
Excellent written and verbal communication skills in English.
Strong analytical skills, attention to detail, and ability to work independently.
Proficiency in Microsoft Office (Word, Excel, PowerPoint).
This position is open to all candidates.
