Senior Regulatory Affairs Specialist
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Job Location:
Riyadh - Saudi Arabia
Monthly Salary:
Not Disclosed
Posted on:
18 hours ago
Vacancies:
1 Vacancy
Job Summary
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
Required Experience:
Senior IC
Key Skills
- Athletics
- Corporate Banking
- Dreamweaver
- Facilities
- IT Support
About Company
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. Alongsid ... View more
