Sr. Regulatory Affairs Specialist

Work Schedule

Environmental Conditions

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.

Join the Customer Channels team at Thermo Fisher Scientific and be at the heart of supporting science! We manage the sales and distribution of millions of products from thousands of suppliers worldwide, ensuring seamless support from discovery to production. Our diagnostic solutions enhance clinical laboratory operations and patient care, while our personalized customer support empowers users throughout their purchasing journey. Come be a part of our dynamic team and help customers effectively utilize our products and services to make a difference!

DESCRIPTION :
At Thermo Fisher Scientific, you'll join our collaborative team making a meaningful impact on global health and scientific advancement. As a Senior Regulatory Affairs Specialist, you'll provide strategic guidance on regulatory pathways, manage submissions, and serve as a subject matter expert on various regulations across multiple jurisdictions. Working closely with cross-functional teams, you'll help develop and implement regulatory strategies that enable the successful commercialization of our advanced products, from initial planning through post-market activities. This position offers excellent opportunities for growth while contributing to our mission of enabling customers to make the world healthier, cleaner, and safer.

REQUIREMENTS :

• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in regulatory affairs in the pharmaceutical, medical device, or diagnostics industry.
• Preferred Fields of Study: life sciences, chemistry, engineering, pharmacy, or related scientific field.
• Additional certifications like RAC (Regulatory Affairs Certification) advantageous
• Experience with product compliance with applicable federal, state, and international regulations, including 21 CFR Part 820 and National Association of Boards of Pharmacy (NABP) regulations.
• Strong knowledge of global regulatory requirements, particularly FDA, EU MDR/IVDR, and other major markets' regulations.
• Knowledge of internal screening processes to conduct daily comprehensive regulatory reviews of new products.
• Experience with organizing and validating device data for submission and registration with the FDA GUDID database.
• Demonstrated success in regulatory strategy development and implementation.
• Expert understanding of quality systems (ISO 13485, GMP/QSR) and risk management principles
• Excellent project management skills with ability to manage multiple projects simultaneously
• Strong analytical and problem-solving capabilities
• Clear written and verbal communication skills
• Experience working effectively in cross-functional team environments
• Fluency in English required; additional languages beneficial
• Experience with change control and post-market surveillance activities
• Strong attention to detail and organizational skills
• Ability to interpret and apply complex regulatory requirements
• Customer-focused mindset with business acumen
• Available for occasional travel (5%-10%)