Regulatory Affairs Specialist II (Post Market Surveillance) - Middletown, VA
About The Position
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. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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
- 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.
Nice To Haves
- Preferred Fields of Study: Life Sciences, Chemistry, Pharmacy, Engineering, or related scientific field
- Additional regulatory affairs certifications beneficial
- Fluency in English required; additional languages beneficial
Responsibilities
- ensure product compliance
- manage regulatory submissions
- maintain product registrations
- support quality management systems
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
