Administrative Support 2

4 days ago

Trumbull, United States The Cooper Companies Full time

**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. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

The RA System Analyst will be responsible for monitoring, data entry and regulatory analysis of current CooperSurgical regulatory information and the transition to support the implementation of new software functionality by way of analyzing current data, identifying gaps with the current data and data entry into the new product systems (for example RIM, PLM, ERP, eQMS).
- Bachelor’s degree (or equivalent)
- Minimum 4 years of relevant industry experience
- Excellent written and verbal communication skills; able to communicate effectively and appropriately with internal and external stakeholders. Must be detail oriented
- Able to work independently as well as part of a team; demonstrated experience building a strong team environment.
- Able to excel in a high-pressure, fast-paced, and ever-changing environment; adapt to frequent changes, delays, or unexpected events while meeting objectives, budgets, and timelines.
- Demonstrated ability to monitor own work to ensure quality, accuracy and thoroughness.
- Strong organizational, analytical and time-management skills.
- Able to self-motivate and work both independently and as part of a team.

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.
- Serve as support on Regulatory-IT projects for implementing or upgrading new/existing systems and technologies to ensure data requirements and accuracy for compliance with regulatory health agency requirements, industry/internal standards and business processes.
- Review and test system configuration to ensure business requirements are addressed.
- Support system development and data upload for enabling business readiness.
- Contribute to the maintenance of system documentation throughout the lifecycle of regulatory systems.
- Work with various systems and tools within Regulatory and IT.
- Work with existing regulatory staff to: add, update or correct regulatory product information into the various software systems.
- Support in-house training to ensure optimal use of templates, processes and tools critical for submission documents and information management.
- Must have experience working on large scale projects as well as handling day-to-day Regulatory operational requests from the business.
- Experience with medical device Regulatory submission dossiers/ documentation.
- International Regulatory submissions experience.
- Proficient in using MS Office Suite, Adobe Acrobat and plug-in tools.

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