Sr. Regulatory Affairs Specialist

Thermo Fisher Scientific • Pittsburgh, PA

5d

About The Position

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 IVD/medical device industry
• Demonstrated expertise in global regulatory requirements (FDA, EU MDR/IVDR, other international regulations)
• Experience preparing and managing regulatory submissions (510(k), PMA, CE marking, technical files)
• Strong knowledge of quality management systems (ISO 13485, GMP, QSR)
• Demonstrated success in regulatory strategy development and implementation
• Experience leading regulatory aspects of product development teams
• Excellent project management and organizational skills
• Strong analytical and problem-solving abilities
• Outstanding written and verbal communication skills
• Ability to interpret and communicate complex regulatory requirements
• Experience with risk management and post-market surveillance activities
• Proficiency in reviewing technical documentation and product labeling
• Ability to work effectively in a matrix organization
• Strong interpersonal skills and ability to build consensus
• Willingness to travel (10-15% typically)
• Ability to adapt to evolving regulatory landscape
• Proficiency with standard office software and regulatory documentation systems

Nice To Haves

• Preferred Fields of Study: Biology, Chemistry, Bioengineering, Pharmacy, or related scientific field
• Professional certifications (e.g., RAC, CCRP) advantageous

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees