Job Description

Role: Regulatory Affairs Specialist

Location : Lake Forest, IL (Onsite)

Key Responsibilities:

• Prepare and manage 510(k), PMA, and EU MDR submissions.
• Ensure compliance with FDA, 21 CFR Part 820, ISO 13485, ISO 14971, and international standards.
• Monitor changes in global regulatory requirements and advise internal stakeholders.
• Review and approve labeling, marketing materials, and product documentation.
• Participate in audits, inspections, and CAPA activities.
• Support cross-functional teams (R&D, Quality, Manufacturing) during product development and regulatory reviews.

Qualification:

• Bachelor's degree in Engineering, Life Sciences, or related field (Master's preferred).
• 4+ years of regulatory affairs experience in the medical device industry.
• Strong knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, EU MDR.
• Proven experience with 510(k) submissions and technical documentation.

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