5 дней назад
Project Manager, MDRIM & Document Management
145 800 - 234 600PLN
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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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