Regulatory Affairs Specialist II (Post Market Surveillance) - Middletown, VA
Thermo Fisher ScientificRole Overview
Thermo Fisher Scientific is hiring a entry-level Regulatory Affairs Specialist II (Post Market Surveillance) - Middletown, VA. This is a full-time role in Middletown. Part of Thermo Fisher Scientific's Pharmacy hiring. Full responsibilities, required qualifications, and the apply link are listed in the description below.
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Job Description
Work Schedule
Standard 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.
REQUIREMENTS
- Advanced 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.
Frequently Asked Questions
How do I apply for the Regulatory Affairs Specialist II (Post Market Surveillance) - Middletown, VA position at Thermo Fisher Scientific?
Use the Apply button above to submit your application directly to Thermo Fisher Scientific. Most applications take less than 5 minutes if your resume and contact details are ready, and you'll be routed to the employer's official application system to finish.
Where is the Regulatory Affairs Specialist II (Post Market Surveillance) - Middletown, VA position at Thermo Fisher Scientific located?
This position is based in Middletown. Thermo Fisher Scientific has not indicated remote or hybrid options for this role, so candidates should plan for on-site work.
What does a Regulatory Affairs Specialist II (Post Market Surveillance) - Middletown, VA at Thermo Fisher Scientific earn?
Thermo Fisher Scientific has not disclosed a salary range in this posting. Many employers share specifics later in the interview process; you can also ask during a recruiter screen if compensation transparency is important to you.
When was the Regulatory Affairs Specialist II (Post Market Surveillance) - Middletown, VA role at Thermo Fisher Scientific posted?
This role was posted on April 22, 2026 (47 days ago). It's still listed as actively hiring; we re-confirm openings against the source system multiple times per day and remove closed roles.
Is the Regulatory Affairs Specialist II (Post Market Surveillance) - Middletown, VA role at Thermo Fisher Scientific entry-level?
Yes. This is an entry-level position. Strong candidates typically have 0-2 years of relevant work experience, internships, or significant project work. Read the full description for any specific qualification requirements Thermo Fisher Scientific has listed.
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