Current jobs related to Senior Regulatory Affairs Specialist - Riyadh, Ar Riyāḑ - Sysmex Saudi Arabia

  • Regulatory Affairs Professional

    2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Sysmex Saudi Arabia Full time

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Sysmex Saudi Arabia. The successful candidate will be responsible for ensuring compliance with regulatory requirements in the Kingdom of Saudi Arabia.

  • Regulatory Affairs Specialist

    2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Client of AreebHR Full time

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at the Client of AreebHR. The successful candidate will be responsible for developing and implementing governance frameworks and policy guidelines, ensuring their application across all organizational units.About the RoleThe Regulatory Affairs Specialist will serve as...

  • Regulatory Affairs Specialist

    3 days ago

    Riyadh, Ar Riyāḑ, Saudi Arabia beBee Careers Full time

    Job DescriptionWe are seeking a highly motivated Regulatory Affairs Specialist to join our team. In this role, you will be responsible for initiating registrations and maintaining local labels for products through coordination and preparation of document packages for regulatory submissions.Your ResponsibilitiesDevelop innovative registration plans and...

  • Regulatory Affairs Specialist

    2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Jurong International Full time

    RequirementsWe are seeking a highly skilled and experienced Risk Governance Expert to join our team. The ideal candidate will have a strong background in compliance, regulatory affairs, or a related field.Bachelor's or Master's degree in Law, Business, Compliance, or a related field.10+ years of experience in compliance, regulatory affairs, or a related...

  • Regulatory Affairs Specialist

    2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia Qiddiya Investment Company Full time

    As a Regulatory Affairs Specialist at Qiddiya Investment Company, you will play a critical role in ensuring compliance with local, regional, and national regulations. You will be responsible for overseeing the permitting processes necessary for our revolutionary development projects, ensuring timely approvals for construction and land use.Key...

  • Regulatory Affairs Professional

    13 hours ago

    Riyadh, Ar Riyāḑ, Saudi Arabia beBee Careers Full time

    Job Description:We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with relevant regulations and guidelines.Key Responsibilities:Support business operations for product registrations within the defined territory,...

  • Regulatory Affairs Professional

    2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia DNA Recruitment Full time

    About the Job">We are seeking a Regulatory Affairs Specialist to join our team at DNA Recruitment.The ideal candidate will have 5 years of experience in regulatory affairs within the pharmaceutical industry, with a strong understanding of local regulations and scientific knowledge.They will be fluent in Arabic and English, with a bachelor's degree or...

  • Regulatory Affairs Professional

    1 week ago

    Riyadh, Ar Riyāḑ, Saudi Arabia F. Hoffmann-La Roche Gruppe Full time

    At F. Hoffmann-La Roche Gruppe, we value your unique qualities and create an environment that fosters personal expression, open dialogue, and genuine connections.The OpportunityWe are seeking a skilled Regulatory Affairs Specialist to initiate registrations and maintain local labels for our products.Develop innovative registration plans and submissions...

  • Regulatory Affairs Specialist

    3 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia DNA Recruitment Full time

    For our multinational client, we are looking for a motivated and well-spoken RA Specialist to lead the KSA country. The role is responsible for RA preparation, submission, follow-up, and approval of new registrations, renewals, and maintenance activities, as well as setting RA plans and executing them across KSA.To be successful in this role, the candidate...

  • Regulatory Affairs Document Coordinator

    2 weeks ago

    Riyadh, Ar Riyāḑ, Saudi Arabia F. Hoffmann-La Roche Gruppe Full time

    In this exciting role as a Regulatory Affairs Specialist at F. Hoffmann-La Roche Gruppe, you will be responsible for ensuring the safe and effective distribution of our products worldwide. This is a challenging and rewarding opportunity for an experienced Regulatory Affairs professional to join our dynamic team.The PositionAbout the RoleAs a Regulatory...

Senior Regulatory Affairs Specialist

1 month ago

Riyadh, Ar Riyāḑ, Saudi Arabia Sysmex Saudi Arabia Full time

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
#J-18808-Ljbffr