Thermo Fisher Scientific · 3 weeks ago
Product Safety Compliance Specialist
Ohio, United States
Full-time
Onsite
Mid Level
3+ years expThermo Fisher Scientific is a global leader in scientific innovation, dedicated to making the world healthier, cleaner, and safer. They are seeking a Product Safety Compliance Specialist responsible for ensuring global product compliance throughout the product lifecycle, focusing on adherence to regulations and standards for medical and laboratory devices.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Contribute as a core team member on New Product Development teams by identifying regulatory requirements, coordinating external certification tests, and publishing technical documentation for global markets
Analyze changes to existing products, define regulatory impacts, and resolve gaps through interaction with testing laboratories and revision of technical documentation
Liaise with testing laboratories for product testing, certifications, and site inspections
Collaborate with Quality, Engineering, and other cross-functions in support of Post-Market Surveillance investigations, field activities, reporting, and initiating product improvements
Engage with regulatory agencies and authorities to register products, resolve questions, and manage issues
Research industry standard methodologies and emerging trends in regulatory compliance to implement regulation changes and improvements
Develop, monitor, and improve internal processes, control systems, and tracking of metrics
Perform all job duties per policies and procedures, in a safe and ethical manner
Qualification
Required
High school diploma or equivalent required
Suggested bachelor's degree in regulatory, project management, or STEM-related field
3+ years experience in quality, compliance, or verification roles
Exposure to manufacturing environments, especially laboratory or medical devices
Involvement with product development and sustaining engineering activities, covering the entire product lifecycle
Working within Product Lifecycle Management systems to review and approve design drawings, specifications, and other technical documents
Participating in post-market surveillance activities such as investigations, root causes, and CAPA
Applying functional knowledge and risk-based analysis in risk assessment activities, such as ISO 12100 or ISO 14971
Strong interpersonal and project management skills, with the ability to handle multiple tasks and prioritize effectively
Detail-orientation, analytical reasoning abilities, investigational curiosity, and systems thinking
Self-starter who works well in fast-paced and cross-functional team environments
Functional understanding of manufacturing processes and product engineering change controls. e.g. ISO 9001, ISO 13485
Awareness of international regulations, standards, and requirements for safety, EMC, wireless, environmental, and circular economy topics. e.g. LVD, RED, RoHS, REACH, 61010-1, 61326-1, 62304-1, etc
Exceptional written and verbal communication skills, with the ability to effectively communicate complex compliance concepts to diverse collaborators
Ethical conduct, integrity, and ability to maintain confidentiality of information
Sit or stand for extended periods on the computer
Use of standard office equipment & Microsoft OS
When onsite, exposure to manufacturing environments with noise, dust, and varying temperatures
Interaction with cross-functional and global teams
Adapt to changing priorities in a fast-paced environment
Travel domestically and internationally up to 10%
Benefits
Competitive remuneration
Annual incentive plan bonus
Healthcare
A range of employee benefits
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Michel Lagarde
Chief Operating Officer
Recent News
CB Insights
2026-01-23
2026-01-22
Company data provided by crunchbase