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

• Assist in preparation of domestic eCopies and other documentation for submission to government agencies (US and international) and distributors
• Support regulatory registrations including establishment, product and product labeling registrations
• Collaborate with Supervisor to update US FDA, EUDAMED, and other regulatory databases
• Obtain government certificates for various submissions and distributor requests
• Maintain international approval history of products and establishments
• Manage regulatory files, databases, and chronologies
• Track submission history and regulatory agency interactions

International Distributor Relations

• Serve as primary point of contact for international distributors
• Support regional registration requirements for new and existing products
• Communicate product changes to international distributors and coordinate implementation activities
• Coordinate timely compilation of materials for license renewals, updates and registrations

Cross-Functional Communication

• Interface with Engineering, Customer Service, Purchasing, Document Control, and Quality Control teams
• Obtain necessary documents and test data to support regional registration requirements
• Update team members on regulatory requirement changes

International Regulatory Submissions

• Plan, coordinate, and assist in preparation of international regulatory submissions and dossiers
• Support registration, listing, technical dossiers, and MDD certification processes
• Prepare and coordinate certified, notarized, legalized and apostilled documentation
• Assist with contracts and tenders

Quality Systems Support

• Perform procedure reviews and prepare updates
• Support product investigations as they relate to regulatory matters

Required Qualifications

Education:

• 4-year college degree preferred, OR
• 2+ years of relevant work experience

Experience:

• 1-4 years of experience in the medical device industry (preferred)

Technical Skills:

• Computer literacy and proficiency in Microsoft Office Suite
• Proficiency in Adobe Acrobat
• Notary public certification (preferred but not required)

Personal Attributes:

• Ability to maintain confidentiality of information and materials
• Strong organizational and communication skills
• Detail-oriented with ability to manage multiple projects simultaneously

What We Offer

• Competitive salary range: $75,000 - $90,000 annually
• Opportunity to work with international distributors and regulatory agencies
• Professional development in the medical device regulatory field
• Collaborative team environment with cross-functional exposure

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.