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Regulatory Affairs Associate II

$40 - $43 per hour

The Fountain Group

North Chicago, IL
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

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Vacancy posted 10 hours ago
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