Senior Regulatory Affairs Specialist Stryker

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

• 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