Regulatory Affairs System Analyst II

CooperCompanies • Trumbull, CT

100d

About The Position

The RA System Analyst supports regulatory operations by managing and optimizing software systems used for regulatory submissions, product information, and compliance documentation. This role bridges technical system expertise with regulatory affairs knowledge to ensure accurate data management, compliance, and efficient workflows.

Requirements

• Familiarity with regulatory systems (e.g., Windchill RIM, eCTD software).
• Hands-on experience with AI technologies in a regulatory or healthcare setting.
• Strong analytical and problem-solving skills.
• Demonstrated ability to learn new systems and applications quickly.
• Experience with medical device Regulatory submission dossiers/documentation.
• Able to work independently as well as part of a team.
• Excellent communication and training abilities.
• Adaptable and flexible.

Responsibilities

• Maintain and optimize regulatory information management systems (RIMS).
• Ensure accurate and timely entry of regulatory data, including product registrations, and submission history.
• Support system upgrades and integrations with AI tools and platforms.
• Identify opportunities to automate manual regulatory workflows using AI process automation.
• Use AI tools to monitor global regulatory changes and assess their impact on company operations.
• Provide training to regulatory staff on system usage and best practices.
• Troubleshoot system issues and coordinate with IT or vendors for resolution.
• Support digital transformation initiatives within Regulatory Affairs.
• Support document management for regulatory submissions.
• Ensure systems align with internal SOPs and external regulatory guidelines.

Benefits

• Outstanding total compensation plan.
• Medical coverage.
• 401(k).
• Parental leave.
• Fertility benefits.
• Paid time off for vacation, personal, sick and holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree