Manager, Distributor and Tender Management

7815-Johnson & Johnson Poland Sp. z o.o. Legal Entity; Poland; On-site; PLN 231,000 - 399,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson in Warsaw, Poland, is seeking a Manager of Distributor and Tender Management to lead Quality Assurance and Regulatory Affairs activities across EMEA distributor and operations-based market models. You will ensure regulatory compliance, support tender participation, and collaborate with cross-functional teams to maintain market access.

The role requires 6–8 years in QA/Regulatory affairs within a regulated industry, strong knowledge of EU/EMEA requirements, and RAC or equivalent

Qualifications

• Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Business, or a related discipline.
• 6–8 years of progressive experience in QA, Regulatory Affairs, operations support, distribution governance, or related roles.
• Regulatory Affairs certification (e.g., RAC) or equivalent preferred.

Responsibilities

• Lead QA and Regulatory Affairs activities for EMEA distributor- and operations-based market models.
• Ensure compliance with local regulations, EU requirements, and QMS standards across distributor/operational environments.
• Serve as primary QARA contact for EMEA 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 tender submissions.

Skills

Analytical Reasoning

Business Writing

Coaching

Compliance Risk

Decision Making

Regulatory Analysis

Regulatory Compliance

Regulatory Development

Regulatory Environment

Risk Assessments

Strategic Thinking

Technical Credibility

Education

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

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 aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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. 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). Strong analytical, risk‑management, and problem‑solving skills. Effective written and verbal communication skills.

Other Language: English required; additional European languages preferred.

Travel: Moderate regional travel across EMEA markets.

Certifications: RAC or equivalent preferred but not required.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

#LI-Hybrid #DePuySynthesCareers

Required Skills: Preferred Skills: Analytical Reasoning, Business Writing, Coaching, Compliance Risk, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility

The anticipated base pay range for this position is: zł231,000.00 - zł399,050.00

Benefits

• an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
• Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.
• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 https://www.jnj.com/.