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Alcon
Alcon
H1B vizasi homiysiIshlab chiqarishKonsaltingSog‘liqni saqlash
Alcon odamlarga ravshan ko‘rish va yanada qulay ko‘rish sharoitida yashashga yordam berishga mo‘ljallangan ko‘z parvarishi mahsulotlarini ishlab chiqadi. Kompaniya faoliyati ko‘rish sohasidagi innovatsiyalar, tadqiqot va ishlanmalar, shuningdek, ko‘z salomatligi uchun mo‘ljallangan mahsulotlar, jumladan, PRECISION7® bir haftalik almashtiriladigan kontakt linzasini ishlab chiqarishni qamrab oladi. Global yo‘nalishga ega sog‘liqni saqlash kompaniyasi sifatida Alcon kundalik hayot sifatini yaxshilashga qaratilgan ko‘rish yechimlarini rivojlantiradi.
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Kompaniyadagi ish o‘rinlari

Manager, Regulatory Operations – Medical Devices | Alcon

Alcon is seeking a regulatory operations manager to lead medical device submission teams and compliance initiatives. The role oversees regulatory data, documentation systems, performance metrics, and process optimization.

USAmerika Qo‘shma ShtatlariCAKaliforniyaTXTexas
119 000 $ – 154 000 $ / yil
OfisdaTo‘liq stavkaO‘rta darajaSeniorTalab Qilinadigan Til: inglizchaMuvofiqlik

Tavsif

  • Manage several regulatory operations programs supporting medical device and pharmaceutical portfolios
  • Direct teams handling dossier development, Clinical Trial Disclosure, submission coordination and publishing, licensing, and labeling activities
  • Make decisions that materially influence project delivery and outcomes
  • Use project management, sophisticated problem-solving, communication, leadership, and sector expertise to achieve objectives
  • Administer controlled document systems, records retention, and information services
  • Follow GxP requirements and standard operating procedures while ensuring documentation accuracy and quality control
  • Advance ongoing process enhancement and regulatory adherence
  • Manage daily team activities, workload, and productivity
  • Design and execute improvements that shorten submission timelines and strengthen documentation quality
  • Establish performance indicators such as cycle time, first-pass yield, and renewal timeliness
  • Review dashboards, reports, operating metrics, and emerging trends
  • Build automated data processes and tracking tools with PowerApps and Power Automate
  • Reconcile regulatory and operational data
  • Prepare and present updates for executive leaders and senior stakeholders
  • Direct cross-functional programs while balancing competing priorities

Talablar

  • Bachelor’s degree or equivalent directly relevant experience; alternatives include a high school diploma with 13 years, an associate degree with 9 years, a master’s degree with 2 years, or a PhD with 1 year of experience
  • At least five years of relevant professional experience
  • At least three years of proven leadership experience
  • Fluent English reading, writing, comprehension, and verbal communication
  • Advanced knowledge of the regulatory submission lifecycle for Class I, II, and III medical devices in the United States, European Union, and Canada
  • Experience entering and maintaining data and managing registration hierarchies
  • Proven project management capability
  • Strong communication and stakeholder relationship skills
  • Ability to structure, prioritize, and advance several projects at once
  • Ability to perform data-quality reviews and validation checks
  • Familiarity with FDA eSTAR, Health Canada REP, and European Union Notified Body submission portals
  • Employer sponsorship and relocation assistance are unavailable; travel availability of 0–10% is required or expected, as applicable to the role
  • 0–10% travel availability

Imtiyozlar

  • Dedicated opportunities for professional growth and development
  • Health insurance and related benefits
  • Life insurance coverage
  • Retirement benefits
  • Flexible time off for exempt associates
  • Paid time off for hourly associates
  • Short- and long-term incentive programs for eligible positions
  • Health and wellness initiatives
  • Programs supporting financial security
  • Resources for retirement planning
  • Reasonable accommodations for qualified individuals with disabilities

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