Regulatory Affairs Associate

Position Overview

Ultimate Staffing Services is actively seeking a dedicated Regulatory Affairs Associate for a prestigious medical device manufacturer in California. This role is pivotal in ensuring compliance with various global regulations, including FDA 21 CFR 820, EN ISO 13485, and the European Medical Regulation (MDR). The successful candidate will manage regulatory documentation and facilitate communication with international distributors to ensure compliance and support global operations.

Responsibilities

• Coordinate and maintain regulatory documentation, including preparation for local and regional registrations, license renewals, and product submissions.
• Ensure timely communication with international distributors to meet regulatory requirements.
• Support the preparation of document packages for regulatory submissions for new products.
• Administer regulatory documentation, including assisting with the preparation of domestic eCopies and other documentation for submission to various agencies.
• Manage regulatory registrations, including product and labeling registrations, and maintain relevant documentation.
• Serve as the point of contact for international distributors, supporting regional registration requirements and communicating product changes.
• Coordinate materials for license renewals and registrations, ensuring timely submission.
• Communicate international requirements to internal teams and update them on changes.
• Prepare and assist in the preparation of international regulatory submissions, contracts, and tenders.
• Support quality systems as they affect regulatory compliance, including procedure reviews 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.
• Proficiency 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, first shift.

Benefits

The position offers a competitive pay range from $36 to $46 per hour, based on experience and qualifications.

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.