Regulatory Affairs Specialist

Sterigenics; Oak Brook (IL); In loco; USD 63.000 - 95.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical benefits

401(k) matching

Paid time off

Financial planning assistance

Parental leave

Education assistance

Voluntary benefits

Employee Assistance Program

Descrizione del lavoro

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.

Competenze

• 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

Mansioni

• 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.

Conoscenze

Attention to detail

Regulatory affairs

FDA knowledge

ISO 13485 knowledge

Documentation control

PCQI/FDQI certification

FSMA knowledge

CAPA experience

Formazione

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

Strumenti

FURLS

CDERDirect

Descrizione del lavoro

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 Responsibilities

• Assist 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 entered
• Assist 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 Required

• Bachelors 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

Special 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 & Benefits

Pay 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 Accounts
• 401(k) program with Company match that immediately vests
• Paid holidays, vacation and sick time
• Free financial planning assistance
• Paid parental leave
• Education assistance
• Voluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet Insurance
• Employee 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 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.