Sr. Specialist, MDRIM & Document Mgmt. (MedTech)

Location: Hybrid role in Warsaw, Masovian, Poland; up to 10% international travel may be required.

Base pay range: PLN 185,500.00–299,000.00

Company

Johnson & Johnson MedTech develops healthcare and medical device solutions through its DePuy Synthes business.

What you will do

• Manage MDRIM and controlled document activities in line with quality systems, regulatory requirements, and internal procedures.
• Maintain accurate regulatory information, metadata, and controlled documentation across applicable systems and repositories.
• Support the creation, review, approval, maintenance, and accessibility of quality and regulatory documents throughout the product lifecycle.
• Partner with Regulatory Affairs, Quality, R&D, Manufacturing, and other stakeholders on submissions, registrations, inspections, and compliance readiness.
• Monitor data and document quality metrics, resolve discrepancies, and contribute to process standardization and continuous improvement.
• Provide subject matter expertise, user training, process guidance, reports, and dashboards for MDRIM and document management.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Quality, Regulatory Affairs, Information Management, or a related discipline.
• 4–6 years of relevant experience in regulatory affairs, quality systems, document management, MDRIM, or a related regulated industry function.
• Experience with controlled documentation, document management systems, quality management systems, and regulatory documentation requirements.
• Strong attention to detail and ability to manage complex documentation and data accurately in a matrixed environment.
• Proficiency with Microsoft Office applications and document management tools.
• Fluency in English is required; Polish is preferred.

Nice to have

• Experience supporting Medical Device Regulatory Information Management processes and systems.
• Familiarity with EU MDR, IVDR, and global medical device regulatory requirements.
• Experience with regulatory submissions, registrations, or product lifecycle management.
• Experience in a global medical device, pharmaceutical, or healthcare organization.
• Knowledge of data governance, document control, and regulatory information management best practices.

Culture & Benefits

• Inclusive work environment guided by Johnson & Johnson’s Credo and focused on health innovation.
• Annual bonus or sales commissions depending on pay grade and location.
• Vacation, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and programs supporting financial, physical, and mental health.
• Insurance plans, service anniversary awards, and recognition programs subject to applicable plan terms.