6 дней назад
Sr. Spec, Restrictions Mgmt & Automation (MedTech)
145 800 - 234 600PLN
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Sr. Spec, Restrictions Mgmt & Automation (MedTech): Managing regulatory and quality-driven restrictions while designing automated workflows, dashboards, and rule-based controls for medical-device market access with an accent on compliance, data governance, and supply continuity. Focus on translating complex regulatory requirements into scalable solutions, optimizing restriction logic, and supporting audits across international markets.
Location: Hybrid in Warsaw, Poland; alternate hybrid locations may be considered in New Cairo, Egypt, or Diegem, Belgium. Up to approximately 10% international travel may be required.
Base pay: zł145,800.00–zł234,600.00 annually.
Company
Johnson & Johnson MedTech develops healthcare and medical-device solutions, with this role supporting DePuy Synthes within QARA International.
What you will do
- Manage global and regional regulatory and quality-driven restriction processes, including interpretation, documentation, execution, and governance.
- Design, implement, and optimize automated workflows, dashboards, rule-based controls, and other digital solutions.
- Partner with Regulatory Affairs, Quality, Supply Chain, Commercial, IT/Digital, and regional teams to assess product-availability and market-access risks.
- Lead restriction-related data governance, master-data quality, documentation standards, and audit readiness.
- Monitor global regulatory and quality changes and update restriction logic and automated controls.
- Provide subject-matter expertise and training while supporting audits, inspections, and continuous-improvement initiatives.
Requirements
- Bachelor’s degree in Life Sciences, Engineering, Information Systems, Regulatory Affairs, or a related field.
- Typically 6–8 years of experience in Quality, Regulatory Affairs, Compliance, Supply Chain, or a related regulated-industry environment.
- Experience managing regulatory or quality-driven restrictions across multiple markets.
- Strong experience with process automation, digital tools, systems optimization, and complex data analysis.
- Understanding of global regulatory frameworks applicable to medical devices and the ability to translate requirements into scalable solutions.
- Fluency in English is required.
Nice to have
- Advanced degree or postgraduate certification.
- Medical-device or highly regulated healthcare-industry experience.
- Hands-on experience with automation, RPA, low-code/no-code platforms, SAP, RIM, or master-data systems.
- Experience supporting regional or global audits and inspections.
- Additional European languages and certifications in Regulatory Affairs, Quality, Lean, Six Sigma, or automation.
Culture & Benefits
- Inclusive work environment focused on individual dignity, diversity, and equal opportunity.
- 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 applicable plans and location.
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