Senior Specialist, Global Regulatory Systems

At CooperVision, a division of CooperCompanies, we’re driven by a unifying purpose to help people to experience life’s beautiful moments. We are connected through our shared values - dedicated, innovative, friendly, partners, and do the right thing. As a leading global manufacturer of contact lenses, we are committed to helping improve the way people see each day. Through our diverse lens portfolio, we tackle the toughest vision challenges – including astigmatism, presbyopia, and childhood myopia. We offer the most complete collection of spherical, toric, and multifocal products available, enabling us to fit 99% of all contact wearers. Learn more at .Job Summary:Supports RA teams in the use of regulatory systems, including Veeva Vault RIM, to enable global product registrations and regulatory activities. Ensures consistent system utilization, resolves user issues, and supports integration with other systems (e.g., eQMS, Agile). Knowledge, Skills and Abilities:5+ years in medical device or pharmaceutical regulatory environment (preferred)Bachelor’s degree in scientific or technical field requiredAdvanced degree or Regulatory Affairs Certification preferredKnowledge of global regulatory requirements (FDA, ISO, MDSAP, Health Canada, LATAM)Experience with regulatory systems (e.g., Veeva Vault RIM)Experience in technical documentation and document management systemsStrong written and verbal communication skillsExperience interpreting regulations and international standardsProcess improvement experience within regulatory or quality systemsExperience with change control and change managementStrong project management, technical writing, analytical, and problem-solving skillsIndependent self-starter; manages time effectivelyHigh attention to detail and organizationAbility to work independently and across global teams including adjust work schedule to adapt to different time zones, as needed. Knowledge of medical device regulations required; or ISO standards preferredVeeva Vault Business certification (or ability to obtain)Proficient in Microsoft Office (Excel, Project, Visio) and Adobe AcrobatFluent in EnglishWork Environment:Office-based with extended computer useOnsite 5- days a week in officeFor U.S. locations that require disclosure of compensation, the starting base pay for this role is between $91,928.00 and $122,570.00 per year and may include cost of living adjustments. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.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.Essential Functions & Accountabilities:Supporting RIM or other systems:Support implementation and improvement of regulatory systems and processes, including: Veeva Vault RIM (communication, adoption, roadmap support, best practices)Acts as the Change Agent providing Technical documentation for submissionsSource of Truth (SOT) data managementUnique Device Identification (UDI)Serve as Veeva Vault RIM Business Administrator in coordination with ITProvide user support, training, and change managementPartner with regional RA teams to identify and implement system improvementsSupport system integration with platforms such as eQMSEnsure required documentation is available within systems and aligned with QMSLiaises with other, non-RA internal functions to assist with ensuring that all documentation required to support global product registration activities is adequately embedded in the QMS and is available in the RIM system for end usersMonitor system usage and support global registration activitiesDevelop and track system performance metricsInvestigate and resolve system-related issues using QMS processesMaintain audit-ready documentationRegistration Activity – supporting regional RA activities:Assist with preparation and submission of regulatory documentation for assigned marketsCollaborate with agencies, consultants, and partners to ensure complete and accurate submissionsMay assist with preparation, compilation, and submitting regulatory documents for the registration of current and new products in assigned markets, as agreed with regional RA leadership. Monitoring Registration Requirements:Identify regulatory requirements with regional RA representativesMaintain knowledge of applicable regulations and standardsCommunicate regulatory requirements and assess impact of changesSupport to CooperVision Processes:Represent regulatory perspective across the organizationProvide guidance on regulatory and quality matters to minimize risk and improve outcomesDeliver training and supportOther duties as assignedTravel: Up to 10% domestic or international travel Full timePosting Date: 2026-06-30