Regulatory Affairs Associate - Compliance Documentation
Company: Ultimate Staffing
Salary Range: $75,000 - $90,000 annually
Position Overview
Ultimate Staffing is seeking a Regulatory Affairs Associate, Compliance Documentation to join our client's team in Mountain View, California. This role is responsible for coordinating, preparing, compiling and maintaining various regulatory documentation, including documentation used in local and regional registration, license renewal and product submissions for mature products. The position also involves continuous and timely communications with international distributors to ensure regulatory requirements are met.
Reporting Structure: Reports to the RA Supervisor - Compliance, International, and Documentation
Key Responsibilities
Regulatory Documentation Administration
International Distributor Relations
Cross-Functional Communication
International Regulatory Submissions
Quality Systems Support
Required Qualifications
Education:
Experience:
Technical Skills:
Personal Attributes:
What We Offer
This position offers an excellent opportunity for career growth in regulatory affairs within the medical device industry, with exposure to both domestic and international regulatory requirements.
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county , to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.
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