CooperSurgical
Overview
Regulatory Affairs System Analyst II role at CooperSurgical. 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. Responsibilities
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: Bachelor’s degree in Life Sciences, Computer Science, Regulatory Affairs, or related field; Certificates, Licenses, and/or Registrations related to Regulatory Affairs or Regulatory/Clinical Operations. Our Benefits
As an employee of CooperSurgical, you\'ll receive an outstanding total compensation plan. We offer medical coverage, 401(k), parental leave, fertility benefits, paid time off, and multiple other perks and benefits. Visit www.coopersurgical.com to learn more about CooperSurgical and the benefits of joining our team. EEO Statement
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.
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Regulatory Affairs System Analyst II role at CooperSurgical. 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. Responsibilities
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: Bachelor’s degree in Life Sciences, Computer Science, Regulatory Affairs, or related field; Certificates, Licenses, and/or Registrations related to Regulatory Affairs or Regulatory/Clinical Operations. Our Benefits
As an employee of CooperSurgical, you\'ll receive an outstanding total compensation plan. We offer medical coverage, 401(k), parental leave, fertility benefits, paid time off, and multiple other perks and benefits. Visit www.coopersurgical.com to learn more about CooperSurgical and the benefits of joining our team. EEO Statement
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.
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