Regulatory Affairs System Analyst II

About CooperSurgical

CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life.

As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments.

Guided by our shared values - dedicated, innovative, friendly, partners, and do the right thing - our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women's and family care, and beyond.

We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions.

Learn more at www.coopersurgical.com .

Work location: Trumbull, CT (on-site)

Scope:

Job Summary:

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.

Essential Functions & Accountabilities:


* System Management & Data Integrity
+ 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.


* Process Optimization & Support
+ 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.


* Regulatory & Clinical Collaboration
+ Support document management for regulatory submissions.
+ Ensure systems align with internal SOPs and external regulatory guidelines.

Travel:


* Occasional travel (less than 5%) to CSI locations or Regulatory meetings, conferences, and audits.

Qualifications

Knowledge, Skills and Abilities:


* 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.


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