Senior Regulatory Affairs Specialist

Full time at Sysmex Saudi Arabia in Saudi Arabia

Posted on February 5, 2025

Job details

Roles and Responsibilities Regulatory

Supporting business operations for product registrations within the defined territory.
Providing visibility and reporting of ongoing product registrations and its status to other stakeholders with the use of the product registration trackers where required.
Communication of expected product design changes received from Legal manufacturers to distributors and authorities, collecting such information from distributors and authorities on their impact, and informing the Legal manufacturer and distributor on actions resulting from these changes.
Communicating and clarifying when required, the registration requirements to the Legal Manufacturers.
Communicating and informing Sysmex legal manufacturers of relevant expected regulatory changes and keeping abreast of such changes in the defined territory.
Providing updates to the management through regulatory intelligence gathered via Commercial team, Distributors, and authorities in the designated territory.
Working together with the Technical Service Team in collating information on any Potential Reportable Events in the designated territory.
File Submission & direct interaction with SFDA; close follow up with the Authorities until registration is finalized.
Shipments release: assessing the import/export requirements for the products, reviewing and submitting required documents, and following up with competent authorities including SASO, MOC, MOI, and customs.

Quality:

Assists in all tasks related to the QMS implementation & ISO certification as well as system upgrade whenever required within KSA Office.
Assist in the monitoring and close out of field corrective actions (FSCAs) in the affected designated territory.
Provides periodic updates of FSCA status to Regulatory and Quality Director and other stakeholders in the designated territory.
Assist in product modification reporting and adverse event reporting to regulatory Authorities within the defined territory, as required.

Qualification

Education: A bachelor's degree in a related field such as life sciences, biomedical engineering, or medical technology.
Regulatory Knowledge: In-depth understanding of KSA regulations and guidelines relevant to IVDs (In Vitro Diagnostic Medical Devices Regulation).
Quality Knowledge: Experience of ISO 13485 is preferable to ensure compliance with the standards as well as certificate maintenance.
Experience: Minimum 3 years work experience in regulatory affairs & quality assurance, preferably in MD/IVD Industry.
Communication and Interpersonal Skills: Excellent written and verbal communication skills are important for interaction with regulatory authorities and cross-functional teams.

About Sysmex LLC Sysmex Corporation supports healthcare professionals around the world in lighting the way with diagnostics by providing a broad range of medical diagnostic products and solutions. In the fields of Haematology, urinalysis, hemostasis, life science, flow cytometry, essential healthcare, and immunochemistry, we combine highly dependable, multi-functional, and easy-to-operate instruments, a variety of reagents and software, plus reliable service and support. Sysmex LLC, located in Riyadh, Saudi Arabia, is a subsidiary of the Sysmex Corporation from Kobe, Japan. From our Riyadh offices, we serve our customers in Saudi Arabia and support healthcare professionals by providing medical diagnostic products, solutions, and services. International Reputation Sysmex ranks among the top diagnostic companies, being a world leader in haematology diagnostics and services. Globally, the company operates in more than 190 countries and regions around the world and employs more than 10,000 people. The company's net sales at the fiscal year ended March 2022 were 2.79 € billion (¥363.7 billion: €1=¥130), with the EMEA region accounting for 27.9% of that amount.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Other
Industries: Medical Equipment Manufacturing

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Senior Regulatory Affairs Specialist

Job details

Seniority level

Employment type

Job function

Apply safely

Hiring company

Sysmex Saudi Arabia

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