Regulatory Affairs Specialist
5 days ago
Job Description:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Sysmex Saudi Arabia. As a key member of our regulatory team, you will be responsible for ensuring compliance with relevant regulations and guidelines in the Kingdom of Saudi Arabia (KSA) and supporting business operations for product registrations.
Main Responsibilities:
- Provide visibility and reporting of ongoing product registrations and its status to stakeholders.
- Communicate expected product design changes received from manufacturers to distributors and authorities.
- Collaborate with the Technical Service Team on collating information on Potential Reportable Events.
- File submission and direct interaction with SFDA; close follow-up until registration is finalized.
- Assess import/export requirements for products, review and submit required documents, and follow up with competent authorities.
About the Role:
This is a mid-senior level role that requires a minimum of 3 years' experience in regulatory affairs & quality assurance, preferably in the Medical Devices/IVD Industry. The ideal candidate will have an in-depth understanding of KSA regulations and guidelines relevant to IVDs and ISO 13485 certification.
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