Specialist, Regulatory Affairs – Middle East & Africa

🔥 0 minutes ago

🇱🇧 Lebanon – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

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🗣️🇸🇦 Arabic Required

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Logo of Abbott

Abbott

10,000+ employees

Founded 1888

🏥 Healthcare

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare • Healthcare Insurance • Biotechnology

Abbott is a global healthcare company committed to advancing medical technologies and improving lives around the world. It offers a broad range of leading products in diagnostics, medical devices, nutrition, and branded generic medicines. Abbott's innovations such as the FreeStyle Libre glucose monitoring systems and BinaxNOW rapid antigen tests are transforming diabetes management and COVID-19 response. Through its partnerships and initiatives, Abbott aims to foster health equity, improve access to healthcare, and address critical health challenges like malnutrition and infectious diseases. Abbott is also dedicated to sustainability and social responsibility, striving to make life-changing technologies accessible and affordable.

📋 Description

• Prepare robust regulatory applications for regulatory agencies in the Middle East and Africa • Review and approve business unit change requests after assessing impacts on regulatory submissions • Review and analyze applicable regulatory guidelines and assessments • Review and evaluate regulatory documentation and provide registration submissions compliant with applicable standards, including Saudi FDA requirements • Maintain current medical device regulations and communicate new or modified requirements to business unit colleagues • Interface directly with Saudi FDA and other regulatory agencies as needed • Comply with FDA, international, EU MDR and other regulatory requirements, as well as company policies and procedures • Collaborate with employees, regulators, distributors and customers • Liaise with Abbott International, Product Divisions, Business Units and International RA staff • Implement databases and tracking tools for projects and commitments • Provide metrics, reports and feedback to management • Support new product introductions, tender and reimbursement activities with regulatory and quality documentation • Build relationships with stakeholders and sales teams and notify them of regulatory updates impacting sales

🎯 Requirements

• Bachelor’s degree in Biology or Science • Some experience or knowledge of regulatory affairs activities and adherence to quality management systems requirements is desirable • Must be proficient in English and Arabic • Knowledge and experience of regulations relevant to the medical device industry • Awareness of the role and remit of local regulatory authorities • Competent user of Microsoft Office packages • Capability and strong working knowledge of Excel is desirable • Good communication skills • Critical thinking and ability to challenge appropriately • Strong attention to detail • Highly organised and efficient, with ability to meet deadlines • Ability to act with honesty and integrity at all times

🏖️ Benefits

• Career development with an international company • Recognition as a great place to work in dozens of countries • Recognition as one of the best big companies to work for and a best place to work for diversity, working mothers, female executives and scientists • Equal Opportunity Employer committed to employee diversity

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