Position Overview

Ultimate Staffing Services is actively seeking a dedicated and detail-oriented Regulatory Affairs Associate to join a reputable medical device manufacturer. This role is based in a global regulated environment, where the candidate will be responsible for coordinating and maintaining various regulatory documentation. The ideal candidate will ensure compliance with FDA 21 CFR 820, EN ISO 13485, and the European Medical Regulation (MDR).

Responsibilities

• Coordinate, prepare, compile, and maintain regulatory documentation for local and regional registration, license renewal, and product submissions.
• Communicate with international distributors to meet regulatory requirements.
• Administer regulatory documentation, including preparation of domestic eCopies and submissions to government and other agencies.
• Assist in regulatory registrations, maintaining relevant documentation, and updating databases such as US FDA and EUDAMED.
• Serve as a point of contact for international distributors, supporting regional registration requirements.
• Communicate product changes to international distributors and coordinate necessary activities for implementation.
• Prepare and assist in the preparation of international regulatory submissions, contracts, and tenders.
• Support quality systems related to regulatory processes, including procedure review and product investigations.

Qualifications

• 4-year college degree preferred or 2 years of relevant work experience.
• 1 to 4 years of experience in the medical device industry preferred.
• Proficient in Microsoft Office Suite and Adobe Acrobat.
• Notary public preferred but not required.
• Ability to maintain confidentiality of information and materials.

Required Work Hours

Monday to Friday, 1st shift

Benefits

Competitive salary ranging from $35 to $40 per hour.

Additional Details

The position offers an opportunity to work with a dynamic team and gain valuable experience in a regulated environment. The role requires a proactive approach and a commitment to ensuring compliance with international standards.

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.