Sr. Regulatory Affairs Specialist

Thermo Fisher Scientific • Pittsburgh, PA

2d • Onsite

About The Position

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

Responsibilities

• Provide strategic guidance on regulatory pathways
• Manage submissions
• Serve as a subject matter expert on various regulations across multiple jurisdictions
• Work closely with cross-functional teams
• Develop and implement regulatory strategies that enable the successful commercialization of our advanced products, from initial planning through post-market activities.

What This Job Offers

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