Associate Director RA Operations & Distributor Management, EMEA

Johnson & Johnson Co.; Starachowice; On-site; PLN 318,000 - 547,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Well-being reimbursement

Insurance plans

Recognition awards

Job summary

Johnson & Johnson is recruiting for an Associate Director, RA Operations & Distributor Management, EMEA, located in Warsaw, Poland. You will drive regulatory execution across EMEA by managing regulatory operations and distributor management activities, collaborating with Global, Regional, and Local Regulatory Affairs teams, and supporting product launches and lifecycle management.

The role requires a Master's degree in a scientific field plus 6+ years in Regulatory Affairs within medical

Qualifications

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

Responsibilities

• Lead regulatory portfolio planning, prioritization, and execution across EMEA.
• Align global, regional, and local regulatory strategies to support business needs.
• Ensure effective execution of Regulatory Affairs activities across distributor markets.
• Build strong partnerships with Regulatory Affairs, Commercial, Quality, and Supply Chain teams.
• Drive improvements in regulatory processes, tools, and ways of working.
• Oversee timely provision of regulatory documentation to local teams through central services.

Skills

Regulatory leadership

Cross-functional collaboration

Strategic planning

Stakeholder management

Analytical problem solving

Communication

AI awareness

Education

Master's degree or equivalent in Science/Engineering

Job description

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

People Leader

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

• 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. Our commitment to inclusion

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives. We are proud to be an equal opportunity employer and welcome applications from qualified candidates of all backgrounds. If you require a reasonable accommodation during the application, interview, or onboarding process, support is available. Please let us know how we can help.

Preferred Skills

• Business Writing
• Compliance Risk
• Developing Others
• Fact-Based Decision Making
• Inclusive Leadership
• Industry Analysis
• Innovation
• Leadership
• Legal Support
• Managing Managers
• Operations Management
• Policy Development
• Product Licensing
• Public Policies
• Regulatory Affairs Management
• Regulatory Compliance
• Regulatory Development
• Regulatory Environment
• Strategic Thinking

The anticipated base pay range for this position is: zł318 000,00 - zł547 400,00

Benefits

• Benefits: In addition to base pay, we offer the following 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.

Company Value Statement

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.

Company Value Statement

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/.