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Salary: PLN 121,000 - 194,350 / annual
Johnson & Johnson's DePuy Synthes is seeking a CQ/RA Specialist to support regulatory and commercial quality compliance for medical devices distributed across the Central and Eastern Europe (CEE) region. This role sits within the QARA International team and is critical to ensuring that regulatory clearances, product notifications, and submissions are delivered on time while maintaining alignment with global quality systems and regulatory expectations.
Key responsibilities include:
- Leading and managing QARA projects with alignment to global and regional quality/regulatory strategies
- Ensuring timely regulatory clearance of medical devices in the distributor portfolio
- Coordinating and preparing product notifications and managing product submissions
- Maintaining and updating RA databases and systems
- Reviewing copy/labeling materials for the CEE Central region
- Providing regulatory support to cross-functional teams including Tender, Health Economics & Reimbursement, Business, Distributors, and Franchises
- Delivering RA training to local clusters
- Communicating regulatory updates and status to management
- Coordinating with Supply Chain, Procurement, and Commercial teams on project execution
- Supporting distributor quality requirements including onboarding, oversight, remediation, and continuous improvement
- Preparing project dashboards and communications for leadership
- Ensuring compliance with internal quality systems, regulatory requirements, and governance standards
- Fostering a culture of compliance and continuous improvement
This is a matrix-oriented role requiring strong cross-functional collaboration in a complex, global distributor environment. Limited travel may be required.
**Requirements:**
- Bachelor's degree in Quality, Regulatory Affairs, Life Sciences, Engineering, Business, or related discipline (Master's degree preferred)
- 3–5 years of relevant professional experience in project management, quality, regulatory, or distributor-related activities in a regulated environment
- Demonstrated experience managing cross-functional, multi-stakeholder projects
- Working knowledge of quality systems, compliance processes, and regulatory-driven requirements
- Ability to communicate clearly with diverse audiences, including senior leadership
- Proven ability to manage multiple priorities in a fast-paced, matrix environment
- Fluency in English required; additional languages are an advantage
- Project Management certification (e.g., PMP, PRINCE2) preferred but not required
**Preferred Experience:**
- Distributor management or third-party oversight within medical devices, pharmaceuticals, or healthcare
- Familiarity with international distributor models and global quality/regulatory expectations
- Process improvement, remediation, or change management initiatives
- Formal project management methodologies (Agile, PRINCE2, PMP)
- Strong planning, organizational, and risk-management skills
