Regulatory Affairs Specialist II - Middletown
2 days ago
Job description
Work ScheduleStandard Office Hours (40/wk)
Environmental Conditions
Office
Job Description
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.
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 you'll ensure product compliance and market access for our innovative diagnostic solutions.
You'll 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.
RequirementsAdvanced Degree with no prior experience, OR Bachelor's 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 States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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