Regulatory Affairs Specialist - Global Device Compliance

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

Benefits offered by this job

Medical benefits

401(k) matching

Paid time off

Financial planning assistance

Parental leave

Education assistance

Voluntary benefits

Employee Assistance Program

Job summary

Sotera Health is seeking a Regulatory Affairs Specialist to support regulatory strategy, maintain registrations and listings, and ensure ongoing compliance across global sites. This role collaborates with Quality, Operations and Sales to guide customers from onboarding through commercialization.

Responsibilities include maintaining FDA registrations, managing FSMA/PCQI, overseeing GDUFA requirements, training staff, and coordinating with global facilities on regulatory filings.

Qualifications

• Bachelor’s 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 preferred
• Must be detail oriented and able to spot errors that require correction
• PCQI/FDQI certification is preferred
• Knowledge of FSMA and associated requirements is preferred
• CAPA and controlled document change experience

Responsibilities

• Maintain registrations and listings for each sterilization site.
• Perform FSMA activities as a PCQI/FDQI.
• Manage the FDA annual update process and ensure listings are current.
• Assist Customer Service with FDA registration questions.
• Oversee GDUFA annual requirements, including fees and facility identification.
• Provide training on annual update process for registration and listings.
• Assist with regulatory projects as needed.
• Monitor FDA Registration inbox and respond.
• Deliver reports for inspections/audits.
• Collaborate with global facilities on regulatory needs for various products.
• Serve as subject matter expert for regulatory registrations and listings.
• Assist with Food Safety and Food Defense plan changes.
• Collaborate on document updates related to regulatory compliance.
• Perform other duties as assigned.

Skills

Attention to detail

Regulatory affairs

FDA knowledge

ISO 13485 knowledge

Documentation control

PCQI/FDQI certification

FSMA knowledge

CAPA experience

Education

Bachelor’s degree in Life Sciences, Engineering, or related field

Tools

FURLS

CDERDirect

Job description

Sotera Health is seeking a Regulatory Affairs Specialist to support regulatory strategy, maintain registrations and listings, and ensure ongoing compliance across global sites. This role collaborates with Quality, Operations and Sales to guide customers from onboarding through commercialization.

Responsibilities include maintaining FDA registrations, managing FSMA/PCQI, overseeing GDUFA requirements, training staff, and coordinating with global facilities on regulatory filings.