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