What Regulatory Affairs Departments Jobs are in Saudi Arabia?
Showing 360 Regulatory Affairs Departments jobs in Saudi Arabia
Job Description
Regulatory Affairs Associate Essity is a leading global hygiene and health company which develops produces and sells Health & Medical Consumer Tissue and Professional Hygiene products and solutions which has a strong global presence. We are looking for a Regulatory Affairs Associate to join our dynamic team in Health and Medical Business Unit in Riyadh and play a pivotal role in shaping the success of the MEA region. Were seeking individuals who embody our core values embrace challenges innovate fearlessly and thrive in a fast-paced environment. If this describes you wed love to connect. About the Role Ensure that the assigned product assortments (for example from different Legal Manufacturers and/or Essity BUs) are compliant with relevant regulations of the assigned country or region over the entire product life cycle. The candidate will provide strategic regulatory affairs guidance to the commercial organisation in their marketing and sales approach and will safeguard the regulatory fit of global launches and relaunches in the country or region. What You Will Do Defining and driving the regulatory strategy for product launches projects and activities in the region/market(s). #Draft&Drive/Track&TraceRegulatoryPlans Registering products and sites in front of the authorities in the assigned country or region in the national language(s) on the basis of the global technical dossier adapted for national regulatory compliance; keeping registrations maintained in collaboration with the global organization where applicable or via providing support to the distributors regulatory teams. # RegisterLocal/EnsuringGlobalCompliance Providing market-relevant regulatory input for a country or region for global innovation and change projects particularly for successful national product registration and claim substantiation. #SupportGlobalPortfolioManagementForLocalization Bridging and adapting the regulatory framework of global projects fo
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Job Description
A leading medical supplies manufacturing company based in Riyadh is seeking a Regulatory Affairs Technical Officer to support and coordinate regulatory activities and ensure compliance with SFDA FDA MDR and ISO 13485 standards. The candidate will be responsible for maintaining technical documentation and engaging with both internal quality teams and external regulatory bodies. Responsibilities: Provide Level 1 and Level 2 technical support related to regulatory submissions. Prepare and update technical documentation (e.g. Risk Management Files Verification Reports PMS plans) in compliance with SFDA FDA MDR and ISO 13485. Submit regulatory files and documents to local and international authorities as required. Interpret and apply global regulatory frameworks to ensure full product compliance. Coordinate closely with the Quality Department for alignment on compliance matters. Draft clear and professional technical reports for both internal and external use. Actively support audit and inspection readiness efforts. Requirements: Bachelors degree in Pharmacy Chemistry Biomedical Engineering or a related scientific or technical field. 01 year experience Quick learner. The company offers comprehensive training in regulatory processes and documentation standards to ensure a successful onboarding experience. Strong English skills in both reading and writing are essential for reviewing regulatory requirements preparing documentation and communicating with global partners. Effective Communication Time Management Team Collaboration Analytical Thinking Regulatory Compliance (SFDA FDA MDR ISO 13485 Technical Documentation Preparation Risk Management & PostMarket Surveillance
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