Regulatory Affairs Specialist Ii (post Market Surveillance) - Middletown, Va
Thermo Fisher Scientific UK
Middletown, VA, United States
Product compliance and market access
Regulatory submissions
Quality management systems
Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer
Job Summary
Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.
You'll ensure product compliance and market access for our innovative diagnostic solutions.
This position offers excellent opportunities for professional growth while contributing to our mission of enabling customers to make the world healthier, cleaner, and safer.
Matching Summary
Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.
Skills & Requirements
Must-have
product compliance and market access
regulatory submissions
quality management systems
global regulatory requirements
product lifecycle management
post-market surveillance and vigilance reporting
Nice-to-have
professional growth opportunities
making the world healthier, cleaner, and safer
additional languages beneficial
work effectively in a matrix organization
Key Requirements
Advanced Degree with no prior experience
Bachelor's Degree plus 2+ years of experience
regulatory affairs certifications beneficial
Comprehensive knowledge of global regulatory requirements
Strong understanding of quality management systems
Experience preparing and reviewing technical documentation
Expertise in change control processes
Proven ability to interpret and apply regulatory requirements
Excellent project management and organizational skills
Strong analytical and problem-solving capabilities
Superior written and verbal communication skills
Proficiency in Microsoft Office and regulatory information management systems
Detail-oriented with strong documentation skills
Demonstrated ability to manage multiple priorities
Must be legally authorized to work in the United States without sponsorship
Work Rights
Must be legally authorized to work in the United States without sponsorship