Manager, Distributor and Tender Management

Johnson Johnson; Warszawa; On-site; PLN 180,000 - 300,000; Full time

Job summary

Johnson & Johnson in Warsaw is seeking a Manager, Distributor and Tender Management to lead QA and Regulatory Affairs activities across EMEA distributor and operations-based models, ensuring regulatory compliance and uninterrupted market access.

You will coordinate regulatory documentation for tenders, work with cross-functional teams, and drive governance improvements to mitigate risk and support commercial growth.

Qualifications

• Bachelor’s degree in Regulatory Affairs, Life Sciences, Engineering, or related discipline.
• 6–8 years of progressive experience in QA, Regulatory Affairs, or distributor governance within a regulated industry.
• Knowledge of EMEA regulatory requirements and distributor obligations.
• Experience supporting distributor-based or operational business models.

Responsibilities

• Lead QA and Regulatory Affairs activities for EMEA distributor- and operations-based models.
• Ensure compliance with local regulations, EU requirements, and company QMS standards.
• Serve as primary QARA point of contact for distributor, operations, and tender activities.
• Lead regulatory and quality support for tender management, including submission obligations.
• Coordinate preparation and delivery of regulatory/quality documentation for tenders.
• Collaborate with regulatory, quality, supply chain, legal and commercial teams to maintain market access.
• Drive continuous improvement to compliance, efficiency, and distributor oversight.

Skills

Quality Assurance

Regulatory Affairs

Distributor governance

Tender management

Cross-functional collaboration

Stakeholder management

Education

Bachelor's degree in Regulatory Affairs/Life Sciences/Engineering

Advanced degree or professional certification in Regulatory Affairs/Quality

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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.

Preferred: Advanced degree or professional certification in Regulatory Affairs, Quality, or a related field.

Experience and Skills

Required

• 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.

Preferred

• Experience supporting multi-country market portfolios.
• Experienc