Regulatory Affairs Specialist II

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll 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'll work with cross-functional teams to manage regulatory submissions, maintain product registrations, and support quality management systems across global markets. 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 • Comprehensive knowledge of global regulatory requirements, particularly FDA, EU IVDR/MDR, and regional regulations • Strong understanding of quality management systems (ISO 13485, GMP, MDSAP) • Experience preparing and reviewing technical documentation and regulatory submissions • Expertise in product lifecycle management and change control processes • 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 • Superior written and verbal communication skills • Fluency in English required; additional languages beneficial • 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 • Experience with post-market surveillance and vigilance reporting