Project Manager, MDRIM & Document Mgmt.

7815-Johnson & Johnson Poland Sp. z o.o. Legal Entity; Starachowice; Hybrid; PLN 146,000 - 235,000; Full time

Job summary

Johnson & Johnson Poland Sp. z o.o. Legal Entity in Warsaw seeks a Project Manager for MDRIM and document management within QARA International.

This hybrid role coordinates Regulatory Affairs, Quality, R&D, and Manufacturing teams to ensure compliant medical device documentation across markets. The role drives cross-functional execution, supports inspection readiness, and has a direct impact on regulatory compliance. English fluency is required; Polish preferred.

Qualifications

• Bachelor degree in Life Sciences, Engineering, Quality, Regulatory Affairs, or related discipline.
• Master’s degree preferred.
• 6–8 years of relevant experience in project management, quality, regulatory, or document management environments.
• Experience managing cross-functional, international projects.
• Knowledge of quality systems, regulatory documentation, and controlled document management.

Responsibilities

• Lead MDRIM and document management projects from initiation through completion, ensuring delivery on time, within scope, and in alignment with QARA priorities.
• Coordinate cross-functional stakeholders to align documentation and regulatory information requirements.
• Oversee planning, tracking, and reporting of project milestones, risks, issues, and dependencies.
• Ensure document management processes comply with global regulations, internal quality standards, and inspection readiness expectations.
• Support continuous improvement initiatives by identifying process gaps and implementing standardized MDRIM and documentation workflows.
• Maintain project documentation, dashboards, and metrics to support transparency and leadership decision-making.
• Facilitate governance meetings, project reviews, and stakeholder communications across QARA International.
• Apply Johnson & Johnson Credo values and quality principles in all project activities.

Skills

Project management

Regulatory knowledge

Quality systems

Cross-functional coordination

Communication skills

English proficiency

Education

Bachelor’s degree

Master’s degree

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: Diegem, Flemish Brabant, Belgium, New Cairo, Cairo, Egypt, Warsaw, Masovian, Poland

Job Description: DePuy Synthes is recruiting for a(n) Project Manager, MDRIM & Document Mgmt, this Hybrid position will be in Warsaw, Poland.

Alternate Hybrid locations may be considered at New Cairo, Egypt and Diegem, Belgium.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

Warsaw, Poland - Requisition Number: 097944

New Cairo, Egypt - Requisition Number: 099996

Diegem, Belgium - Requisition Number: 097944

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Job Overview This role leads and coordinates MDRIM (Medical Device Regulatory Information Management) and document management projects within QARA International, ensuring regulatory documentation, data, and processes meet global and regional requirements. The Project Manager drives cross‑functional execution, improves quality and compliance processes, and supports operational readiness across international markets. This position offers the opportunity to have a direct impact on regulatory compliance, inspection readiness, and the efficient lifecycle management of medical device documentation.

Key Responsibilities

• Lead and manage MDRIM and document management projects from initiation through completion, ensuring delivery on time, within scope, and in alignment with QARA priorities.
• Coordinate cross‑functional stakeholders (Regulatory Affairs, Quality, R&D, Manufacturing, and external partners) to align documentation and regulatory information requirements.
• Oversee planning, tracking, and reporting of project milestones, risks, issues, and dependencies.
• Ensure document management processes comply with applicable global regulations, internal quality standards, and inspection readiness expectations.
• Support continuous improvement initiatives by identifying process gaps and implementing standardized, efficient MDRIM and documentation workflows.
• Maintain project documentation, dashboards, and metrics to support transparency and leadership decision‑making.
• Facilitate governance meetings, project reviews, and stakeholder communications across QARA International.
• Apply Johnson & Johnson Credo values and quality principles in all project activities.

Qualifications

Education: Bachelor’s degree required in Life Sciences, Engineering, Quality, Regulatory Affairs, or a related discipline. Master’s degree preferred.

Experience and Skills:

Required: 6–8 years of relevant experience in project management, quality, regulatory, or document management environments within a regulated industry (medical devices, pharmaceuticals, or healthcare preferred). Demonstrated experience managing cross‑functional, international projects. Working knowledge of quality systems, regulatory documentation, and controlled document management processes.

Preferred: Experience supporting MDRIM, regulatory information management, or global submissions. Familiarity with EU MDR/IVDR and global regulatory expectations.

Experience working in matrixed, global organizations.

Project management certification (e.g., PMP, PRINCE2) preferred.

Strong organizational, planning, and risk management skills.

Effective written and verbal communication skills with the ability to influence stakeholders.

Other: Language: Fluency in English required; Polish preferred. Travel: Limited; up to 10–20% international travel may be 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

Required Skills:

Preferred Skills

• Analytical Reasoning
• Business Behavior
• Business Writing
• Communication
• Confidentiality
• Data Reporting
• Detail‑Oriented
• Legal Support
• Medicines and Device Development and Regulation
• Problem Solving
• Product Licensing
• Regulatory Affairs Management
• Regulatory Compliance
• Regulatory Development
• Regulatory Environment
• Risk Assessments
• Teamwork

The anticipated base pay range for this position is: zł145,800.00 - zł234,600.00

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. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers. *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/.

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