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Regulatory Affairs Intern

CooperVision

Regulatory Affairs Intern

Rochester, NY
Internship
Paid
  • Responsibilities

    Regulatory Affairs Intern CooperVision, a unit of The Cooper

    Companies, Inc.(NYSE:COO), is one of the worlds leading manufacturers of soft contact lensesand related products and services. The Company produces a full array ofmonthly, two-week and 1-day lenses, all featuring advanced materials andoptics. CooperVision has a strong heritage of solving the toughest visionchallenges such as astigmatism and presbyopia; and offers the most completecollection of spherical, toric and multifocal products available. Through acombination of innovative products and focused practitioner support, thecompany brings a refreshing perspective to the marketplace, creating realadvantages for customers and wearers. For more information, visit www.coopervision.com. ** ** JOB TITLE: RegulatoryAffairs Intern DEPARTMENT: GlobalLabeling ** ** JOB SUMMARY ** ** The Regulatory Affairs Internship position will primarilysupport Global Regulatory Labeling Compliance. They will collaborate withGlobal Quality and Global Supply Chain interns to investigate and report on anElectronic Quality Management System project. ESSENTIALFUNCTIONS** ** * Responsible for the investigationinto an eQMS project and presenting information to cross functional teams. * Assisting Global Regulatory andGlobal Quality on labeling / packaging projects as needed. * Collaborates with regional regulatory affairspersonnel pertaining to labeling. * Responsible for executingcomparative analysis of regulatory submissions, eQMS and websites to ensurelabeling compliance. * Presents monthly progressreports to the RAQA team for labeling projects. * Executes gap assessments of current packagingrequirements / (content masters). * Assists with the continuousimprovement of Global Regulatory Labeling Compliance processes relating topackaging and labeling. * Assist with obtainingtranslations for Global Content Masters and Lens Care Solutions projects, asneeded. * Ability to communicate andinterpret regulatory requirements as requested. * Conducts other RA support asneeded. SCOPE ** ** Responsiblefor an eQMS analysis project. Regular interaction with different functionaldepartments including Global Packaging, Supply Chain, IT, etc. as they interactwith the Quality System. POSITIONQUALIFICATIONS KNOWLEDGE, SKILLSAND ABILITIES * Excellent oral and written communication skills,with ability to communicate with diverse populations * Able to analyze regulations * Must be proficient with Microsoft Office including the ability todevelop MS PowerPoint presentations and Excel spreadsheets. Advanced skills arepreferred. * Project management, technical writing andanalytical skills * Ability to read and understand highly technicalmaterial. * Complies with all company policies andprocedures. * Complies with management direction. Seeksassistance from supervisor in identifying and reporting problems or concernsrelated to job functions. * Conducts self in a professional manner withcoworkers, management, customers, and others. Models the cooperate values. * Professional demeanor and able to work withcross-functional groups. * Needs to have good interpersonal, teamwork, andcommunication skills (both verbal and written). * Ability to meet deadlines. * Well organized with attention to detail andability to carry out tasks independently * Ability to meet deadlines_ _ WORK ENVIRONMENT * Typical office work environment. * Prolonged sitting in front of a computer._ _ EDUCATION * Bachelors degree in a scientific or technicaldiscipline from a four year college or university. or working towardsa post-graduate degree._ _ EXPERIENCE * Medical Device experiences is not required, butpreferred. * Technical background is preferred. **Primary Location: **United States-New York-Rochester **Work Locations: ** **Job: **Regulatory Affairs **Organization: **CooperVision. **Schedule: **Full-time

  • Industry
    Manufacturing