Manager, Regulatory Affairs

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 collaborative team at Thermo Fisher Scientific as a Regulatory Affairs Manager, where you'll make a meaningful impact on global healthcare. You'll guide strategic regulatory initiatives for our innovative medical devices, in-vitro diagnostics, and clinical research services. Working closely with cross-functional teams, you'll ensure regulatory compliance while supporting product development and market access. This role offers the opportunity to shape regulatory strategy, interact with global health authorities, and drive excellence in submission quality across multiple jurisdictions.

REQUIREMENTS:
• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in regulatory affairs in medical device, IVD, or pharmaceutical industries
• Preferred Fields of Study: Life Sciences, Chemistry, Biology, Pharmacy or related scientific field
• Professional certifications in Regulatory Affairs (RAC) beneficial
• Comprehensive knowledge of global regulations including FDA, EU MDR/IVDR, ICH guidelines
• Expert understanding of regulatory submission requirements (510(k), CE marking, technical files)
• Strong experience managing regulatory submissions and agency interactions
• Advanced project management and organizational skills
• Demonstrated leadership ability and experience managing regulatory teams
• Strong written and verbal communication skills
• Excellent interpersonal skills for cross-functional collaboration
• Strong analytical and problem-solving capabilities
• Proficiency with regulatory submission tools and documentation systems
• Experience with quality management systems and GMP requirements
• Knowledge of clinical trial regulations and requirements
• Ability to interpret and implement new regulatory requirements
• Travel required 10-20%
• Fluency in English required; additional languages beneficial