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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)Sr. Specialist, MDRIM & Document Mgmt., located in Warsaw, Poland.

Job Overview 

The Sr. Specialist, MDRIM & Document Management is responsible for supporting the management, maintenance, and governance of regulatory information and controlled documentation within QARA International. This role serves as a subject matter expert for MDRIM and document management processes, ensuring regulatory data integrity, document compliance, and adherence to global quality and regulatory requirements. 

The Sr. Specialist partners closely with Regulatory Affairs, Quality, R&D, Manufacturing, and other cross-functional stakeholders to support regulatory submissions, product lifecycle activities, inspections, and continuous process improvements. This role contributes to operational excellence by ensuring accurate, compliant, and efficient management of regulatory information and documentation across international markets. 

Key Responsibilities 

• Manage and maintain MDRIM and controlled document management activities in accordance with established quality systems, regulatory requirements, and internal procedures. 

• Ensure the accuracy, completeness, and integrity of regulatory information, metadata, and controlled documents within applicable systems and repositories. 

• Support the creation, review, processing, approval, and maintenance of quality and regulatory documentation throughout the product lifecycle. 

• Collaborate with Regulatory Affairs, Quality, R&D, Manufacturing, and other stakeholders to ensure documentation and regulatory information requirements are met. 

• Provide subject matter expertise on document management processes, data governance standards, workflows, and system requirements. 

• Monitor document and data quality metrics, identify discrepancies, and drive timely resolution of documentation and regulatory information issues. 

• Support regulatory submission and registration activities by ensuring required documentation and data are maintained and readily accessible. 

• Contribute to inspection, audit, and compliance readiness efforts through effective document control and regulatory information management practices. 

• Participate in continuous improvement initiatives to enhance MDRIM and document management processes, standardization, efficiency, and compliance. 

• Assist with user training, process guidance, and procedural updates related to MDRIM and document management activities. 

• Maintain documentation records, reports, and dashboards to support operational reviews and management decision-making. 

• Apply DePuy Synthes quality principles and Johnson & Johnson Credo values in all activities. 

Qualifications 

Education 

• Bachelor's degree required in Life Sciences, Engineering, Quality, Regulatory Affairs, Information Management, or a related discipline. 

• Master's degree preferred. 

Experience and Skills 

Required 

• 4-6 years of relevant experience in regulatory affairs, quality systems, document management, MDRIM, or related functions within a regulated industry. 

• Experience working with controlled documentation and document management systems. 

• Knowledge of quality management systems and regulatory documentation requirements. 

• Strong attention to detail with demonstrated ability to manage complex documentation and data accurately. 

• Experience collaborating across functions in a matrixed environment. 

• Proficiency with Microsoft Office applications and document management tools. 

Preferred 

• Experience supporting MDRIM (Medical Device Regulatory Information Management) processes and systems. 

• Familiarity with EU MDR, IVDR, and applicable global medical device regulatory requirements. 

• Experience supporting regulatory submissions, registrations, or product lifecycle management activities. 

• Experience working in a global medical device, pharmaceutical, or healthcare organization. 

• Knowledge of data governance, document control, and regulatory information management best practices. 

Other 

• Language: Fluency in English required; Polish preferred; additional languages are an advantage.

• Travel: Limited; up to 10% 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.

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Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking

  

 

The anticipated base pay range for this position is:

zł185,500.00 - zł299,000.00

 

 

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.