Regulatory Affairs Specialist

Sterigenics; Oak Brook (IL); On-site; USD 63,000 - 95,000; Full time

Job summary

Sotera Health is seeking a Regulatory Affairs Specialist to support regulatory strategy, registrations, and listings for its Sterilization sites. You will work with Quality, Operations, and Sales to guide customers from onboarding to commercialization, ensuring ongoing compliance with FDA and ISO 13485 requirements.

The role involves FSMA/PCQI activities, FDA annual updates, and collaboration across global facilities to maintain regulatory readiness and effective documentation controls.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or related field is required.
• At least two years of regulatory affairs experience in medical devices, pharmaceuticals, tissue or food.
• Working knowledge of FDA, ISO 13485, and applicable regulations.
• Familiarity with FDA registration/listing systems such as FURLS and CDER is preferred.
• PCQI/FDQI certification is preferred; CAPA and controlled document changes experience is a plus.

Responsibilities

• Assist RAM with maintenance of registrations and listings for sterilization sites.
• Handle FSMA-related activities as PCQI/FDQI and support FDA annual updates.
• Support facility Customer Service with FDA registration/listing inquiries.
• Manage GDUFA annual requirements, including payments and self-identification.
• Provide training on annual update processes for registrations/listings.
• Monitor regulatory inbox, respond to inquiries, and prepare facility reports for inspections.
• Collaborate with global facilities and act as SME for regulatory registrations/listings.
• Assist with Food Safety and Food Defense plan updates; support document updates for compliance.

Skills

Regulatory affairs experience

FDA registration familiarity

CAPA experience

Document control/change management

FSMA/PCQI/FDQI knowledge

Education

Bachelor's degree in Life Sciences/Engineering

Tools

FURLS

CDER

Job description

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.Duties and ResponsibilitiesAssist the Regulatory Affairs Manager (RAM) with the maintenance and upkeep of registration and listings for each of the sterilization sites.Perform activities for Food Safety Modernization Act (FSMA) as a Preventive Control Qualified Individual (PCQI) and/or Food Defense Qualified Individual (FDQI).Manage the FDA annual update process to ensure that all listings are received and enteredAssist facility Customer Service with questions from customers relating to FDA registration and listings.Manage the GDUFA (Generic Drug User Fee Amendment) annual requirements, including fee payments and self-identification of the relevant facilities.Timely response to Customer Service requests for urgent listings from customers.Provide training to new Customer Service representatives on the annual update process for registration and listings.Assist the Regulatory Affairs Manager with regulatory projects as needed.Monitor the FDA Registration email inbox and respond as appropriate.Deliver reports of specific facility information to be presented at inspections/audits.Work with global facilities to understand what is needed for each based on what products are being processed.Act as the subject matter expert for regulatory registrations and listings.Assist with Food Safety and Food Defense plan changes for the facilities.Collaborate with the Regulatory Affairs Manager on document updates needed as related to regulatory compliance.Performs other duties as assigned.SUPERVISION GIVEN:May supervise daily workflow of Regulatory Affairs activities or other staff.Experience and Skills RequiredBachelors degree in Life Sciences, Engineering, or related field.Two years of related regulatory affairs experience in Medical Device, Pharmaceuticals, Tissue or Food.Working knowledge of FDA, ISO 13485, and other applicable government regulations.Familiarity with the FDA registration and listing systems such as FURLS and CDERDirect is preferredMust be detail oriented and able to spot errors that require correctionPCQI/FDQI certification is preferredKnowledge of FSMA and associated requirements is preferredCAPA and controlled document change experienceSPECIAL REQUIREMENTS:Prolonged periods sitting at a desk and working on a computer.Must be able to lift up to 15 pounds at times.TRAINING REQUIRED:Regulatory Affairs Specialists must understand all aspects of product development, including research, clinical trials, manufacturing practices, regulations, and approval processes.Pay & BenefitsPay Rate: $63,000–$95,000 annually, based on experience.Sotera Health offers a competitive benefits package that includes:Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts401(k) program with Company match that immediately vestsPaid holidays, vacation and sick timeFree financial planning assistancePaid parental leaveEducation assistanceVoluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet InsuranceEmployee Assistance Program (EAP)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 ContractorSotera 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.