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5 дней назад

Project Manager, MDRIM & Document Management

145 800 - 234 600PLN
Формат работы
hybrid
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
Poland/Belgium/Egypt
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
Project Manager, MDRIM & Document Management (Medical Device Regulatory Information Management): Leading MDRIM and document management projects for regulated medical device operations with an accent on regulatory documentation, quality systems, and cross-functional international delivery. Focus on coordinating project milestones, improving compliant documentation workflows, and supporting inspection readiness across global and regional markets.

Location: Hybrid position in Warsaw, Poland; alternate hybrid locations may be considered in New Cairo, Egypt, or Diegem, Belgium. Limited international travel of up to 10–20% may be required.

Base pay: zł145,800.00–zł234,600.00 per year.

Company

Johnson & Johnson MedTech develops healthcare and medical device solutions, with DePuy Synthes focused on orthopaedics.

What you will do

  • Lead MDRIM and document management projects from initiation through completion.
  • Coordinate Regulatory Affairs, Quality, R&D, Manufacturing, and external stakeholders.
  • Plan, track, and report project milestones, risks, issues, and dependencies.
  • Ensure documentation processes meet global regulations, internal quality standards, and inspection-readiness expectations.
  • Identify process gaps and implement standardized MDRIM and document management workflows.
  • Maintain project documentation, dashboards, metrics, governance meetings, and stakeholder communications.

Requirements

  • Bachelor’s degree in Life Sciences, Engineering, Quality, Regulatory Affairs, or a related discipline.
  • 6–8 years of relevant experience in project management, quality, regulatory, or document management within a regulated industry.
  • Experience managing cross-functional, international projects.
  • Working knowledge of quality systems, regulatory documentation, and controlled document management processes.
  • Fluency in English is required.
  • Strong organizational, planning, risk management, communication, and stakeholder-influencing skills.

Nice to have

  • Master’s degree.
  • Experience with MDRIM, regulatory information management, or global submissions.
  • Familiarity with EU MDR/IVDR and global regulatory expectations.
  • Experience in matrixed, global organizations.
  • Project management certification such as PMP or PRINCE2; Polish language skills.

Culture & Benefits

  • Inclusive work environment guided by the Johnson & Johnson Credo.
  • Annual bonus or sales commissions depending on pay grade and location.
  • Vacation, parental, bereavement, caregiver, and volunteer leave.
  • Well-being reimbursement and financial, physical, and mental health programs.
  • Insurance plans and service anniversary and recognition awards, subject to plan terms.

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