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 AffairsFDA PMA submissionsPMA SupplementsClass III implantable medical devices30-Day NoticesReal-Time Reviews180-Day SupplementsAnnual ReportsRegulatory submissions and amendmentsFDA regulatory agency interactionsFDA PMA guidance21 CFR regulationsRegulatory strategyProduct change controlManufacturing change assessmentEngineering study protocols and reportsValidation study protocols and reports6+ years of pharmaceutical, medical device, or industry experience3-5 years of regulatory affairs, quality systems, or cross-functional project management experienceRecent Class III implantable medical device experienceExperience authoring, submitting, and obtaining approval for Class III PMA supplements Preferred Skills 6+ years of pharmaceutical industry experience5+ years of Regulatory Affairs experienceExperience in Discovery, R&D, or Manufacturing environmentsExperience managing regulatory activities across complex, matrixed organizationsExperience developing regulatory strategies for product changes and submissions