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Regulatory Affairs Officer

4 weken geleden

Rotterdam, Nederland United Imaging Healthcare Europe Voltijd

Main Responsibilities:
# Take the responsibility for the company's product certification program, and complete the registration and/or marketing authorization activities for related products according to the requirements of the corresponding regional/national regulatory agencies in the international market
# Track and update international market regulatory requirements
# Interpret laws and regulatory requirements of various regions/countries in the international market to ensure product regulatory compliance.
# Support each business unit with assistance and guidance on international market regulations.
# Undertake and complete work tasks assigned by superiors.


Qualification Requirements::
Educational Background : Bachelor’s degree or higher in engineering
Relevant Experience : Over 2 years of work experience and have relevant work experience in Cybersecurity Law, Data Security Law, Personal Information Protection Law, Cybersecurity Level Protection Regulations or work experience in medical device companies or medical device agency companies and have an experience in active medical device product registration and regulatory engineers.
# Professional knowledge/ Technologie : Overseas Electronic Product Certification Regulations
# Good communication, coordination and teamwork skills
# Good English writing and communication skills