SDG Regulatory Specialist II MEA

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. DESCRIPTION: Join our team at Thermo Fisher Scientific as a Regulatory Affairs Specialist II, where you'll ensure product compliance and market access for our innovative diagnostic solutions. You will work with cross-functional teams to manage regulatory submissions and maintain product registrations across Middle East and Africa region. This position offers excellent opportunities for professional growth while contributing to our mission of enabling customers to make the world healthier, cleaner, and safer. REQUIREMENTS: • Advanced Degree with no prior experience, or Bachelor's Degree plus 2 years of experience in regulatory affairs, preferably in IVD/medical device industry • Preferred Fields of Study: Life Sciences, Chemistry, Pharmacy, Engineering, or related scientific field • Additional regulatory affairs certifications beneficial • A Keen understanding of regulatory requirements for IVD’s and Medical Devices in territories of Middle East and Africa such as Saudi Arabia SFDA, Nigeria NAFDAC, Ethiopia EFDA, Tanzania TMDA, Algeria ANPP , U.A.E MOHAP • Fluency in English and Arabic; additional languages beneficial • Experience preparing and reviewing technical documentation and regulatory submissions with knowledge of IVDR/MDR • Proven ability to interpret and apply regulatory requirements to product development and maintenance • Excellent project management and organizational skills • Strong analytical and problem-solving capabilities • Strong interpersonal skills, with ability to deliver messages clearly and succinctly • Proficiency in Microsoft Office and regulatory information management systems • Ability to work effectively in a matrix organization and cross-functional teams • Detail-oriented with strong documentation skills • Demonstrated ability to manage multiple priorities and meet deadlines