Manager, Distributor and Tender Management

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Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Warsaw, Masovian, Poland

Job Description:

DePuy Synthes is recruiting for a(n) Manager, Distributor and Tender Management located in Warsaw, Poland.

Job Overview

The Manager, Distributor and Tender Management 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. This role is accountable for maintaining regulatory compliance, distributor governance, quality system effectiveness, and uninterrupted market access across diverse and highly regulated market

The position plays a critical role in enabling compliant business operations, sustaining commercial growth through successful tender participation, and supporting business continuity. The Manager collaborates closely with Regulatory Affairs, Quality, Supply Chain, Commercial, Legal, and Global QARA partners to manage risk, drive compliance, and support efficient distributor and tender management processes across the region

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 and objectives.

·         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 a thorough understanding of country-specific regulatory requirements and tender submission obligations.

·         Coordinate the preparation, review, and delivery of regulatory and quality documentation required to support tender submissions, ensuring accuracy, completeness, and adherence to submission timelines.

·         Partner with commercial, regulatory, and operational stakeholders to support successful tender participation, maintain market access, and mitigate business risks associated with tender activities.

·         Support as required 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 that documentation requests are completed 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 across EMEA.

·         Drive continuous improvement initiatives that enhance regulatory compliance, operational efficiency, distributor oversight, and overall business effectiveness.

Qualifications

Education

• Required: Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, Business, or a related discipline.
• Prefe…