Regulatory Affairs Associate II

Job Title: Regulatory Affairs Specialist 
Location: North Chicago, IL – Hybrid
Pay Rate: $40 - $43/hour
Duration: Through August 2027

Job Description

• Prepare and submit regulatory applications, amendments, renewals, annual reports, supplements, and variations for regulated products.
• Author and submit FDA PMA supplements, including 30-Day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports.
• Manage regulatory submissions and respond to regulatory agency requests and information.
• Prepare and manage agency meeting materials and pre-meeting submissions.
• Evaluate regulatory requirements and interpret information impacting regulatory strategies and submissions.
• Manage product changes and change controls in accordance with applicable regulations and company procedures.
• Review and approve engineering study protocols and reports, and validation study protocols and reports.
• Review and approve manufacturing changes for Class III implantable medical devices.
• Support regulatory activities in complex, matrixed pharmaceutical, medical device, or life sciences environments.

Education

• Bachelor's degree in Pharmacy, Biology, Chemistry, Pharmacology, Engineering, or a related scientific/technical discipline.
• Advanced degree preferred.

Skills

• Regulatory Affairs
• FDA PMA submissions
• PMA Supplements
• Class III implantable medical devices
• 30-Day Notices
• Real-Time Reviews
• 180-Day Supplements
• Annual Reports
• Regulatory submissions and amendments
• FDA regulatory agency interactions
• FDA PMA guidance
• 21 CFR regulations
• Regulatory strategy
• Product change control
• Manufacturing change assessment
• Engineering study protocols and reports
• Validation study protocols and reports
• 6+ years of pharmaceutical, medical device, or industry experience
• 3–5 years of regulatory affairs, quality systems, or cross-functional project management experience
• Recent Class III implantable medical device experience
• Experience authoring, submitting, and obtaining approval for Class III PMA supplements

Preferred Skills

• 6+ years of pharmaceutical industry experience
• 5+ years of Regulatory Affairs experience
• Experience in Discovery, R&D, or Manufacturing environments
• Experience managing regulatory activities across complex, matrixed organizations
• Experience developing regulatory strategies for product changes and submissions