Regulatory Affairs System Analyst II
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Job Location:
Trumbull, CT - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
About CooperSurgical
CooperSurgical is a leading fertility and womens 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 were driven by a unified purpose to enable patients to experience lifes 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 womens 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.
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.
Adaptable and flexible
Experience:
- 3 years experience in Regulatory Affairs Regulatory/Clinical Operations or System Analysis.
Education:
- Bachelors degree in Life Sciences Computer Science Regulatory Affairs or related field.
- Certificates Licenses and/or Registrations related to Regulatory Affairs or Regulatory/Clinical Operations
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Our Benefits:
As an employee of CooperSurgical youll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck we offer a great compensation package medical coverage 401(k) parental leave fertility benefits paid time off for vacation personal sick and holidays and multiple other perks and benefits. Please visit us atto learn more about CooperSurgical and the benefits of becoming a member of our team.
To all agencies: Please no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email the internet or in any form and/or method will be deemed the sole property of CooperSurgical unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race color ancestry religion sex national origin sexual orientation age citizenship marital status disability gender gender identity or expression or veteran status. We are proud to be an equal opportunity workplace.
Required Experience:
IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
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