Senior Regulatory Affairs Specialist
Schaumburg, IL 60195 US
Title: Senior Regulatory Affairs Specialist
Location: Schaumburg, IL
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Hire Type: Direct hire
- Ensures on-time filing of high-quality regulatory submissions, and to assemble, maintain, and control regulatory dossiers, Annual Reports, licenses/registrations, quality agreements and QMS regulatory requirements.
- Provides regulatory assistance to regulatory specialist(s). Interacts with all levels in the organization, and across several functions, including Marketing, R&D, engineering, manufacturing and QA/QC.
- Interfaces with regulatory agencies, including the FDA, Health Canada and Latin America distributors or government agencies as appropriate, as it relates to submissions, regulatory compliance, post market surveillance, field action and other relevant topics.
- Responsible for ensuring regulatory compliance requirements are met, monitors regulatory notices/updates and changes in enforcement by the FDA, Health Canada and other global regulatory agencies where SAI products are distributed as well as ensures any signals from post market surveillance which may affect the QMS state, effectiveness or comprehensiveness are identified, escalated, impact/risk assessed, and action taken to ensure compliance to regulatory requirements.
- Undertakes literature searches for the Pharmacovigilance project to meet regulatory requirements.
- Interprets and presents the finding of literature searches.
- Additional duties related to Regulatory Affairs (a more detailed job description will be provided to candidates after a brief qualifying phone screen).
- Bachelor’s Degree in a related technical field.
- 7+ years of regulatory and compliance experience in medical device and 510(k) applications, Complaints, and Post Market Surveillance.
- Thorough understanding of the CFRs, FDA, QSRs, cGXPs, ICH and global standards as they pertain to medical devices and pharmaceuticals including regulatory intelligence gathering, regulatory impact assessments, risk management and change control.
- Ability to create a submission to a regulatory agency using an application that creates and validates an electronic Common Technical Document (eCTD)
- Knowledge of regulations and industry best practices for publishing
- Working knowledge of compliance requirements in Europe. Latin America, Asia and Canada.
- Excellent writing and editing skills necessary for regulatory documentation using Word, Excel, PowerPoint, etc as well as verbal communication and presentation skills.
- Knowledgeable in QMS requirements, CAPA, Change control, CGxP including Risk Management.
- Regulatory Affairs Certification (RAC) preferred.
Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information