Regulatory Affairs Associate II

Our client, a leading organization in the medical device industry, is seeking a Regulatory Affairs Associate II to join their team. As a Regulatory Affairs Associate II, you will be part of the Global Regulatory Affairs department supporting regulatory submissions and compliance efforts. The ideal candidate will have strong attention to detail, proactive communication skills, and a collaborative mindset, which will align successfully in the organization.

Regulatory Affairs Associate II

Lake Forest, IL

$25-35

Monday-Friday, 8:00 AM - 5:00 PM

• Provide regulatory support and expertise for US and global submission requirements.
• Assist in the creation and maintenance of global registration dossiers to ensure compliance.
• Track and manage regulatory deliverables to meet project deadlines.
• Review technical reports and critical documents for regulatory submissions.
• Coordinate with regional regulatory teams to evaluate changes and ensure regulatory compliance.

• Bachelor’s Degree in pharmacy, biology, chemistry, pharmacology, engineering, or related field.
• Two or more years of experience in regulatory affairs within the medical device industry.
• Strong understanding of FDA, EU, and global submission requirements.
• Experience assembling global dossiers and preparing regulatory submissions.
• Excellent communication, problem-solving, and project management skills.

• Opportunity to work in a dynamic and innovative environment.
• Potential for temp-to-perm employment based on performance.
• Collaborative team culture that values diversity and inclusion.
• Work in a hybrid setting with flexible locations in Lake Forest, San Clemente, or San Diego.
• Competitive hourly pay rate of $35.00/hour.

• Medical and Prescription Drug Plans
• Supplemental Life Insurance
• Short Term Disability Insurance
• 401(k)

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!