1 час назад
Manager, Distributor and Tender Management (MedTech)
231 000 - 399 050PLN
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Manager, Distributor and Tender Management (MedTech): Leading Quality Assurance and Regulatory Affairs activities for distributor and operations-based market models across EMEA, with an accent on regulatory compliance, tender submissions, distributor governance, and market access. Focus on coordinating country-specific documentation, managing cross-functional risks, and improving quality and regulatory processes across highly regulated medical device markets.
Location: Warsaw, Masovian, Poland; hybrid work arrangement; moderate regional travel across EMEA markets.
Base pay: zł231,000.00–zł399,050.00 annually, plus an annual bonus or sales commissions depending on the applicable plan.
Company
Johnson & Johnson MedTech develops healthcare and medical device solutions, with this role supporting the DePuy Synthes orthopaedics business.
What you will do
- Lead Quality Assurance and Regulatory Affairs activities supporting EMEA distributor and operations-based market models.
- Provide regulatory and quality support for tender participation, including country-specific requirements and submission obligations.
- Coordinate the preparation, review, and delivery of accurate regulatory and quality documentation for tenders.
- Support distributor onboarding, qualification, oversight, performance monitoring, and compliance governance.
- Develop and improve distributor governance processes, controls, inspection readiness, and operational efficiency.
- Partner with Regulatory Affairs, Quality, Supply Chain, Legal, Commercial, and global QARA stakeholders to maintain market access and compliant product supply.
Requirements
- Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, Business, or a related discipline.
- 6–8 years of progressive experience in Quality Assurance, Regulatory Affairs, operations support, distribution governance, or a related regulated-industry role.
- Strong understanding of EMEA regulatory requirements, distributor obligations, and operational compliance.
- Experience supporting distributor-based or operational business models and managing complex topics in a matrixed environment.
- English is required; additional European languages are preferred.
- Ability to travel moderately across EMEA markets.
Nice to have
- Advanced degree or professional certification in Regulatory Affairs or Quality.
- Experience with multi-country market portfolios, regulatory inspections, quality audits, or health authority interactions across EMEA.
- Experience in medical devices, healthcare, or another highly regulated industry.
- RAC certification or equivalent.
- Analytical, risk-management, problem-solving, communication, and process-improvement skills.
Culture & Benefits
- Inclusive work environment focused on employee diversity and dignity.
- Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
- Well-being reimbursement and financial, physical, and mental health programs.
- Insurance plans, service anniversary awards, and recognition programs subject to applicable plans and location eligibility.
- The orthopaedics business is planned to separate into a standalone DePuy Synthes company, subject to legal, regulatory, and consultation requirements.
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