PR/086981 | RA specialist

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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