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Salary: PLN 231,000 - 399,050 / annual
DePuy Synthes (Johnson & Johnson MedTech) is seeking a Manager, Distributor and Tender Management based in Warsaw, Poland. This role provides leadership for Quality Assurance and Regulatory Affairs activities supporting distributor- and operations-based market models across EMEA, while ensuring effective regulatory support for tender participation and execution.
The Manager is accountable for maintaining regulatory compliance, distributor governance, quality system effectiveness, and uninterrupted market access across diverse and highly regulated markets. The position plays a critical role in enabling compliant business operations, sustaining commercial growth through successful tender participation, and supporting business continuity.
Key Responsibilities:
- Lead and manage Quality Assurance and Regulatory Affairs activities supporting EMEA distributor- and operations-based market models in alignment with global QARA strategies.
- Ensure compliance with applicable local regulations, EU requirements, internal policies, and DePuy Synthes Quality Management System standards across distributor and operational environments.
- Serve as the primary QARA point of contact for EMEA distributor, operations, and tender-related activities.
- Lead regulatory and quality support for tender management activities, ensuring thorough understanding of country-specific regulatory requirements and tender submission obligations.
- Coordinate preparation, review, and delivery of regulatory and quality documentation required to support tender submissions, ensuring accuracy, completeness, and adherence to timelines.
- Partner with commercial, regulatory, and operational stakeholders to support successful tender participation, maintain market access, and mitigate business risks.
- Support CQ/RA Partners for distributor management processes, including onboarding, qualification, oversight, performance monitoring, and compliance governance.
- Ensure distributors maintain required regulatory and quality documentation and complete documentation requests accurately and within defined timelines.
- Develop, implement, and continuously improve distributor governance processes and controls to strengthen compliance, reduce operational risk, and ensure inspection readiness.
- Monitor regulatory, quality, and operational changes across EMEA markets and assess potential impacts on product registrations, distribution models, supply continuity, and business operations.
- Partner with Regulatory Affairs, Quality, Supply Chain, Legal, and Commercial teams to address local market requirements and support compliant product supply.
- Drive continuous improvement initiatives that enhance regulatory compliance, operational efficiency, distributor oversight, and overall business effectiveness.
Note: Johnson & Johnson has announced plans to separate its Orthopaedics business to establish DePuy Synthes as a standalone company. The separation is anticipated to be completed within 18 to 24 months. Following the transaction, you would become an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans.
Requirements:
Education:
- Required: Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Business, or a related discipline.
- Preferred: Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field.
Experience and Skills:
- 6–8 years of progressive experience in Quality Assurance, Regulatory Affairs, operations support, distribution governance, or related roles within a regulated industry.
- Strong understanding of EMEA regulatory requirements, distributor obligations, and operational compliance expectations.
- Experience supporting distributor-based and/or operational business models.
- Ability to manage cross-functional stakeholders and complex operational topics in a matrixed environment.
- Strong analytical, risk-management, and problem-solving skills.
- Effective written and verbal communication skills.
- Moderate regional travel across EMEA markets required.
Preferred:
- Experience supporting multi-country market portfolios.
- Experience working in a global or matrixed organization.
- Exposure to regulatory inspections, quality audits, or health authority interactions across EMEA markets.
- Demonstrated experience contributing to process improvement or operational transformation initiatives.
- Background in medical devices, healthcare, or other highly regulated industries.
- Regulatory Affairs or Quality certification (e.g., RAC or equivalent).
- English required; additional European languages preferred.
