Job description

The Senior Regulatory Affairs Specialist at Johnson & Johnson MedTech (DePuy Synthes) is responsible for providing regulatory support across the Gulf, Levant, and Iraq region. The role encompasses forecasting and planning annual submissions aligned with business priorities, managing product lifecycle for the portfolio, compiling submission dossiers for new registrations, re-registrations, listings, changes, and customs clearance according to local country rules and regulations. The specialist ensures timely submission, follow-up, and approval of registration and market authorization applications, maintaining full regulatory compliance for product launches. The position requires cross-functional collaboration with marketing, sales, operations, and global regulatory teams, managing regulatory documents for tender requests, anticipating and flagging risks with proposed solutions, and maintaining internal databases per SOPs. The role also involves building strong relationships with external stakeholders and distributors, conducting follow-ups, providing training on internal processes, and conducting FSCA, FSN, and complaints reporting. Where applicable, the specialist reviews marketing materials and submits for Health Authority approval. Proficiency in Arabic and English, regulatory experience in medical devices, and understanding of the regional regulatory landscape are critical.