Oak Brook, Illinois, United States · On-site
$63k–$95k/yr
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Regulatory Strategy, FDA Registration, Compliance Monitoring, ISO 13485, FURLS
Salt Lake City, Utah, United States · On-site
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Warehouse management, Inventory control, Shipping and distribution, Regulatory compliance, cGMP
Salt Lake City, Utah, United States · On-site
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Salesforce Administration, CRM Strategy, Sales Operations, Commercial Analytics, Data Governance
Town of Queensbury, New York, United States · On-site
$43k–$62k/yr
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Forklift operation, Warehouse operations, Inventory verification, Data entry, Shipping
Oak Brook, Illinois, United States · Hybrid
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: People Operations, HRIS, Process Improvement, Data Analysis, Leadership
Charlotte, North Carolina, United States · On-site
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Equipment monitoring, Process control, Sterilization procedures, Preventative maintenance, Forklift operation
Gurnee, Alabama, United States · On-site
$46k–$72k/yr
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Leadership, Sterilization process, Forklift operation, Team coordination, Documentation
San Diego, California, United States · On-site
$63k–$95k/yr
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Preventative maintenance, Mechanical troubleshooting, Electrical troubleshooting, 480 volt 3 Phase power, Ladder logic
Fort Worth, Texas, United States · On-site
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Operations Management, Sterilization Services, Lab Testing, Quality Assurance, Safety Compliance
Oak Brook, Illinois, United States · On-site
$134k–$227k/yr
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Strategic HR leadership, Employee relations, People analytics, Workforce planning, Organizational development
Santa Teresa, New Mexico, United States · On-site
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: System monitoring, Equipment maintenance, Forklift operation, Process documentation, Safety compliance
Salt Lake City, Utah, United States · On-site
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: People management, Leadership, Conflict resolution, Problem solving, Communication skills
Salt Lake City, Utah, United States · On-site
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Equipment monitoring, Pressure monitoring, Temperature monitoring, Humidity monitoring, Valve operation
Mulberry, Georgia, United States · On-site
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Conveyor operation, Load and unload, Data entry, Dosimeter operation, Mechanical maintenance
Marion, Indiana, United States · On-site
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Quality Assurance, Regulatory Compliance, Auditing, Process Validation, Risk Analysis
Fleurus, Wallonia, Belgium · On-site
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Sterilization, Lab Testing, Safety Compliance, Quality Assurance, Manufacturing Operations
Ciudad de México, Mexico · On-site
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: General Management, Strategic Planning, Operations Management, Leadership, Quality Assurance
Schaumburg, Illinois, United States · On-site
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Loading And Unloading, Dosimetry, Data Entry, Tape Measure Usage, Forklift Operation
Ottawa, Ontario, Canada · On-site
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Mechanical Design, Engineering Analysis, Prototyping, Testing and Troubleshooting, Manufacturing Process Documentation
West Memphis, Arkansas, United States · On-site
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provide…
Skills: Conveyor Operation, Dosimeter Reading, Forklift Driving, Computer Skills, Basic Mathematics
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The specialist supports regulatory strategy by maintaining registrations and listings to ensure global compliance. They collaborate with Quality, Operations, and Sales to guide customers from onboarding through commercialization.
Requires a Bachelor's degree in Life Sciences or Engineering and two years of regulatory experience in medical devices, pharmaceuticals, tissue, or food. Proficiency with FDA regulations and registration systems is essential, with PCQI/FDQI certification preferred.
The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.
Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.
Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.
The Regulatory Affairs Specialist supports the regulatory strategy, prepares and maintains registrations and listings, and ensures ongoing compliance with global regulatory bodies. This role partners closely with Quality, Operations and Sales and Marketing to help guide customers from onboarding through commercialization.
Regulatory Affairs Specialists must understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes.
Pay Rate: $63,000–$95,000 annually, based on experience.
Sotera Health offers a competitive benefits package that includes:
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Sterigenics U.S. LLC takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities. We strongly encourage those from underrepresented groups to apply.
VEVRAA Federal Contractor
Sotera Health goes to market through its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.
Sotera Health brings together Sterigenics, Nelson Labs and Nordion, each of which are established, highly reputable players in the global health arena. Working as a team, Sotera Health and its companies have one common goal: Safeguarding Global Health®. With these three companies operating together, Sotera Health, formerly Sterigenics International, leverages more than 500 combined years of scientific expertise to ensure safety across the medical device, pharma, tissue and food industries. With over 2,800 employees globally, including more than 350 scientists, the company operates 63 facilities worldwide across 13 countries. Our purpose is bigger than the products and services we provide. We ensure that health care around the world is consistently and reliably safe every day. Our purpose, our conduct, and our values are at the heart of our commitment to employee safety, environmental responsibility, and sustainability principles. The Sotera Health name is new, but our track record for reliability and safety in global health is well established. Formed in 2017 as the parent company for Nelson Labs, Nordion and Sterigenics, Sotera Health is the leader in protecting global health thanks to the longstanding reputation for quality across each of its companies. In aggregate, Sotera Health has over 185 years of combined industry leadership. Sterigenics has provided safe sterilization services since the 1930s. Nordion has established expertise in gamma technologies and medical isotopes since 1946. Nelson Labs has provided expert lab testing since 1985. Our most recent addition to the Sotera Health family, Toxikon Europe, has established a leading extractables and leachables testing platform since 1990. An impressive history that points to an even brighter future.
Offices: 9100 South Hills Blvd, Suite 300, Broadview Heights, Ohio 44147, US
Sotera Health brings together Sterigenics, Nelson Labs and Nordion, each of which are established, highly reputable players in the global health arena. Working as a team, Sotera Health and its companies have one common goal: Safeguarding Global Health®. With these three companies operating together, Sotera Health, formerly Sterigenics International, leverages more than 500 combined years of scientific expertise to ensure safety across the medical device, pharma, tissue and food industries. With over 2,800 employees globally, including more than 350 scientists, the company operates 63 facilities worldwide across 13 countries. Our purpose is bigger than the products and services we provide. We ensure that health care around the world is consistently and reliably safe every day. Our purpose, our conduct, and our values are at the heart of our commitment to employee safety, environmental responsibility, and sustainability principles. The Sotera Health name is new, but our track record for reliability and safety in global health is well established. Formed in 2017 as the parent company for Nelson Labs, Nordion and Sterigenics, Sotera Health is the leader in protecting global health thanks to the longstanding reputation for quality across each of its companies. In aggregate, Sotera Health has over 185 years of combined industry leadership. Sterigenics has provided safe sterilization services since the 1930s. Nordion has established expertise in gamma technologies and medical isotopes since 1946. Nelson Labs has provided expert lab testing since 1985. Our most recent addition to the Sotera Health family, Toxikon Europe, has established a leading extractables and leachables testing platform since 1990. An impressive history that points to an even brighter future.
Offices: 9100 South Hills Blvd, Suite 300, Broadview Heights, Ohio 44147, US
