h3 Technologies
Regulatory Affairs Operations Specialist
h3 Technologies, Deerfield, Illinois, United States, 60063
Position Description
Required Education • Bachelor's degree (scientific or related discipline preferred). • Minimum 5 years of experience in a regulated environment (pharma, biotech, medical devices, etc.).
Required Skills • Technical Proficiency: Word processing, spreadsheets, databases, and online research tools. • Regulatory Knowledge: Understanding of applicable regulations and compliance requirements. • Organizational & Project Management: Ability to manage multiple projects and deadlines efficiently. • Communication & Collaboration: Strong written/verbal skills; adept at negotiation and teamwork. • Problem-Solving: Ability to identify compliance risks and escalate/resolve issues effectively. • Attention to Detail: Ensures accuracy in documentation and regulatory submissions. • Independence: Works with minimal supervision while contributing to cross-functional projects.
Under limited supervision, the Regulatory Systems Specialist is responsible for implementing regulatory strategies, resolving submission-related issues, and ensuring compliance with regulatory requirements.
Key duties include: • Documenting system issues, identifying resolutions, and managing complex process documentation. • Supporting system upgrades to ensure data integrity and proper functionality of tools/version updates. • Maintaining electronic records, receip,t and submission systems for regulatory authorities. • Collaborating with project teams to provide expertise on compliance and system solutions. • Monitoring regulatory changes, assessing potential impacts, and mitigating compliance risks.
Required Education • Bachelor's degree (scientific or related discipline preferred). • Minimum 5 years of experience in a regulated environment (pharma, biotech, medical devices, etc.).
Required Skills • Technical Proficiency: Word processing, spreadsheets, databases, and online research tools. • Regulatory Knowledge: Understanding of applicable regulations and compliance requirements. • Organizational & Project Management: Ability to manage multiple projects and deadlines efficiently. • Communication & Collaboration: Strong written/verbal skills; adept at negotiation and teamwork. • Problem-Solving: Ability to identify compliance risks and escalate/resolve issues effectively. • Attention to Detail: Ensures accuracy in documentation and regulatory submissions. • Independence: Works with minimal supervision while contributing to cross-functional projects.
Under limited supervision, the Regulatory Systems Specialist is responsible for implementing regulatory strategies, resolving submission-related issues, and ensuring compliance with regulatory requirements.
Key duties include: • Documenting system issues, identifying resolutions, and managing complex process documentation. • Supporting system upgrades to ensure data integrity and proper functionality of tools/version updates. • Maintaining electronic records, receip,t and submission systems for regulatory authorities. • Collaborating with project teams to provide expertise on compliance and system solutions. • Monitoring regulatory changes, assessing potential impacts, and mitigating compliance risks.