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4 дня назад

Regulatory Affairs Coordinator (Medtech)

Формат работы
onsite
Тип работы
fulltime
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Regulatory Affairs Coordinator (Medtech): Supporting regulatory affairs administration and assessing new regulatory information for its impact on medical products and processes with an accent on regulatory intelligence, submissions, and process documentation. Focus on monitoring international requirements, assembling agency submission packages, tracking deliverables, and improving regulatory templates and processes.

Location: San Francisco, CA, United States; full-time onsite role

Company

hirify.global provides staffing and professional services, with this role supporting regulatory affairs activities for medical technology products.

What you will do

  • Provide administrative support for the Regulatory Affairs Department.
  • Gather, document, maintain, and distribute regulatory intelligence for pre-market and post-market requirements in the United States and internationally.
  • Monitor new and revised regulatory requirements and assess their impact on products and processes.
  • Compile electronic and hardcopy information packages for submission to regulatory agencies.
  • Define, monitor, and receive submission deliverables.
  • Coordinate department scheduling, expense submissions, travel planning, purchase orders, and vendor creation.

Requirements

  • Bachelor’s degree or related experience.
  • Ability to work independently with complex technologies, office automation programs, and corporate database tools.
  • Ability to manage multiple tasks, prioritize work, and deliver assignments under timeline pressure.
  • Excellent written and oral communication skills.
  • Ability to gather, write, edit, and assemble regulatory memos and product or system information.
  • Strong work ethic and consistent on-time delivery.

Culture & Benefits

  • Full-time employment.
  • Confidential handling of candidate information according to EEO guidelines.

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