Riyadh, SAU
16 hours ago
Senior Regulatory Affairs Specialist
**Summary :** The Senior Regulatory Affairs (RA) Specialist is responsible for interfacing with key members of the regulatory organization and assisting in the implementation of regulatory strategies as defined by the MENA business team and communicated through the EMEA central regulatory group **What you will do :** + Obtain product registration dossiers from EMEA Central RA and tailor them to meet country registration requirements + Develop close collaboration and communication with central RA groups in EEMEA to ensure timely execution of the MEA RA plan. + Communicate with Stryker consultants and distributors across MENA to track and ensure timely dossier submission to the relevant authority + Assist the Stryker Customer Service team and local dealers in preparing country specific regulatory documentation for customs clearance in the MENA region + Create and maintain a registration database for MENA countries. + Responsible for the local demo process, including ordering & maintenance of Stryker MENA demo inventory. + Ensure complete traceability and storage of the products according to the ISO13485:2016 standard. + Intermittently support ISO13485:2016 implementation project. **What you need :** + A minimum of a B.S degree in science/engineering, or related field and minimum 4 years’ experience in Regulatory Affairs in an international organizational business environment + Quality-focused experience within the medical device industry is a plus + Prior experience in product registration of Medical Devices in KSA is required. MENA region experience is a plus + Understanding of International Standards, in particular: ISO13485, is desirable. + Proficiency in English + Strong project management skills + High ethical standards and integrity + Excellent interpersonal relationship building skills + Process consciousness + Good analytical and problem solving skills + Action oriented , achiever, result driven + Good communication skills + Business oriented Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
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