Associate Director RA Operations & Distributor Management, EMEA

Johnson & Johnson Co.; Warszawa; On-site; PLN 400,000 - 700,000; Full time

Job summary

DePuy Synthes, part of Johnson & Johnson, seeks an Associate Director, RA Operations & Distributor Management, EMEA in Warsaw, to drive regulatory execution across the region and oversee distributor management. You will coordinate with global, regional, and local RA teams and partner with Commercial, Quality, and Supply Chain to support launches, lifecycle activities and strategic priorities.

You will lead regulatory portfolio planning, ensure alignment across regions, and manage central

Qualifications

• Master's degree or equivalent in Science, Engineering, or another relevant field.
• Minimum of 6 years of Regulatory Affairs experience within the medical device industry.
• Experience leading complex cross-functional programs in a matrix organization.

Responsibilities

• Lead regulatory portfolio planning across EMEA and distributor markets.
• Align global, regional, and local regulatory strategies to support business needs.
• Oversee regulatory documentation and timelines to local teams in a timely manner.
• Lead, coach, and develop contractors, trainees, and other resources.
• Manage priorities, resources, and budget within a matrix environment.

Skills

Regulatory leadership

Cross-functional leadership

Strategic planning

Stakeholder management

Communication skills

AI awareness

Education

Master's degree in Science/Engineering

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: People Leader

All Job Posting Locations: Warsaw, Masovian, Poland

Job Description

DePuy Synthes is recruiting for an Associate Director, RA Operations & Distributor Management, EMEA located in Warsaw, Poland.

Purpose

We are looking for an Associate Director, RA Operations & Distributor Management, EMEA to join DePuy Synthes.

In this role, you will drive regulatory execution across EMEA by managing regulatory operations and distributor management activities. Working closely with Global, Regional, and Local Regulatory Affairs teams, as well as Commercial, Quality, Supply Chain, and other key partners, you will support product launches, lifecycle management activities, and strategic business priorities.

Are you interested in leading regulatory operations across a diverse EMEA portfolio while helping ensure timely execution of regulatory activities that support patients and healthcare professionals across the region?

You will be responsible for

In this role, you will provide leadership for regulatory portfolio planning, distributor market execution, and operational activities across EMEA. You will help ensure regulatory priorities are aligned across regions and functions while supporting efficient execution of product lifecycle activities and regulatory commitments.

Key responsibilities include:

• Leading regulatory portfolio planning, prioritization, and execution across EMEA
• Aligning global, regional, and local regulatory strategies to support business needs
• Ensuring effective execution of Regulatory Affairs activities across distributor markets
• Building strong partnerships with Regulatory Affairs, Commercial, Quality, Supply Chain, and other cross-functional teams
• Driving improvements in regulatory processes, tools, and ways of working
• Overseeing the timely provision of regulatory documentation to local teams through leadership of central services activities
• Leading the MDRIM Management team
• Supporting regulatory activities associated with commercial tender processes
• Leading, coaching, and developing contractors, trainees, and other assigned resources
• Managing priorities, resources, and budget activities within a matrix environment
• Identifying risks, resolving issues, and calling out significant challenges when required
• Supporting communication and coordination between regional, local, and global partners to ensure effective execution of regulatory activities

Qualifications / Requirements

Education

Master's degree or equivalent in Science, Engineering, or another relevant field

Experience

• Minimum of 6 years of Regulatory Affairs experience within the medical device industry
• Experience leading complex cross-functional programs and managing multiple priorities
• Experience working within a matrix organization and collaborating across functions and geographies

Knowledge & Skills

• Strong understanding of medical device regulations and regulatory requirements across EMEA
• Strong strategic planning, analytical, and problem-solving skills
• Excellent communication, presentation, and stakeholder management skills
• Demonstrated ability to influence senior stakeholders within a matrix organization
• Ability to work independently and make sound, timely decisions
• Ability to identify and manage risks while maintaining focus on business priorities
• Strong collaboration and leadership capabilities
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

What we offer

We offer a collaborative environment where learning, innovation, and professional development are encouraged.

In this role, you will have the opportunity to work across global and regional Regulatory Affairs organizations, contribute to strategic portfolio decisions, and support innovative medical technologies that help improve patient outcomes.