Regulatory Affairs Specialist

Do you want to create a significant impact on patients with brain aneurysms life?

EndoStream is the place for you!!

EndoStream Medical is a small, yet diverse company, with talented multidisciplinary team, who is committed to developing safe and effective solutions to enhance clinical outcomes for patients with brain aneurysms.

If you are a Regulatory Affairs professional, eager to create and observe A-Z processes, and you also like to dive into the small details – look at this great opportunity and join us while we are growing 😊

Key Responsibilities:

• 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 the Technical Documentation, ensuring it remains compliant with applicable regulatory requirements.
• Manage and maintain EUDAMED registration and ensure compliance with EU MDR 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.
• Support post-market surveillance (PMS) and post-market clinical follow-up (PMCF) activities.
• Review clinical evaluation reports (CER).
• Manage vigilance reporting and recall activities.
• Participate in regulatory audits and inspections.

Qualifications & Experience:

• Bachelor’s 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).