CQ/RA Specialist
Employer · 7160-Johnson & Johnson Kft. Legal Entity
Licensing officer
Legal specialist
Quality inspectorFull-timeBudapest
The CQ/RA Specialist plays a key role within QARA International, responsible for regulatory and commercial quality compliance of medical devices distributed on the CEE Central Region market. This role ensures RA and CQ initiatives are delivered on time, in alignment with DePuy Synthes quality systems and regulatory expectations.
Tasks
- Lead and manage QARA projects, ensuring alignment with global and regional quality and regulatory strategies.
- Ensure regulatory clearance of medical devices being in product portfolio of MDs within timelines.
- Coordination and preparation of product notifications.
- Managing product submissions.
- Responsible for updates and approvals in systems linked to job duties and maintaining RA databases.
- Review of copy review materials for CEE Central region.
- Provide regulatory support to relevant teams and partners.
- Coordinate cross-functional stakeholders to drive project execution.
- Support implementation and maintenance of distributor quality requirements.