POSITION TITLE Regulatory Affairs Assistant
POSITION SUMMARY
A global medical device company is seeking a Regulatory Affairs Assistant to support regulatory submissions in the United States and Canada. This role offers the opportunity to work in a cross-functional, international environment, including collaboration with regulatory teams in Japan. Ideal for professionals with experience in regulatory affairs who are looking to grow their career in a dynamic and global setting.
RESPONSIBILITIES
Assist in preparing and submitting regulatory documentation for FDA and Health Canada
Organize, review, and manage submission materials in compliance with regulatory standards
Support the development and maintenance of departmental policies and procedures
Maintain accurate and compliant regulatory files
Prepare meeting materials and assist in presentations
Communicate effectively with international regulatory teams
Provide administrative and operational support to the Regulatory Affairs Director
QUALIFICATIONS
3+ years of experience in regulatory affairs, preferably in the medical device or healthcare industry
Knowledge of FDA and Health Canada regulatory processes
Strong communication skills in English; Japanese proficiency is a plus
Excellent organizational and time management skills
Ability to work independently and collaboratively in a global team
Proficiency in Microsoft Office (Word, Excel, PowerPoint)
LOCATION Irvine, CA (Hybrid work)
SALARY USD80,000-100,000
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