Regulatory Affairs Specialist II (Post Market Surveillance) Middletown, VA

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

Location: Middletown VA. Relocation assistance is NOT provided.


DESCRIPTION:
Join our team at Thermo Fisher Scientific as a Regulatory Affairs Specialist II (Post Market Surveillance) where youll ensure product compliance and market access for our innovative diagnostic solutions. Youll work with cross-functional teams to manage regulatory submissions maintain product registrations and support quality management systems across global markets. This position offers excellent opportunities for professional growth while contributing to our mission of enabling customers to make the world healthier cleaner and safer.

REQUIREMENTS:
Advanced Degree with no prior experience OR Bachelors Degree plus 2 years of experience in regulatory affairs preferably in IVD/medical device industry
Preferred Fields of Study: Life Sciences Chemistry Pharmacy Engineering or related scientific field
Additional regulatory affairs certifications beneficial
Comprehensive knowledge of global regulatory requirements particularly FDA EU IVDR/MDR and regional regulations
Strong understanding of quality management systems (ISO 13485 GMP MDSAP)
Experience preparing and reviewing technical documentation and regulatory submissions
Expertise in product lifecycle management and change control processes
Proven ability to interpret and apply regulatory requirements to product development and maintenance
Excellent project management and organizational skills
Strong analytical and problem-solving capabilities
Superior written and verbal communication skills
Fluency in English required; additional languages beneficial
Proficiency in Microsoft Office and regulatory information management systems
Ability to work effectively in a matrix organization and cross-functional teams
Detail-oriented with strong documentation skills
Demonstrated ability to manage multiple priorities and meet deadlines
Experience with post-market surveillance and vigilance reporting

*Must be legally authorized to work in the United Stateswithoutsponsorship.

*Must be able to pass a comprehensive background check whichincludes a drug screening.