Regulatory Affairs Specialist

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...