Regulatory Operations Intern

4 days ago

Richmond Hill, Canada STERIS Full time

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

**Position Summary**:
The Corporate Regulatory Department is looking for energetic, dynamic and team-oriented individuals to complement our group’s mission to diligently execute critical compliance initiatives. This dynamic role as a Regulatory Operations Intern will provide exposure to many of the regulations, standards, and practices that define the regulatory landscape and govern the medical device industry.

**Key Internship Info**:

- Dates: Summer 2025 (May-August) with opportunities to extend
- Location: Richmond Hill, Ontario, CAN
- Work Environment: Hybrid

**What You'll do as a Regulatory Operations Intern**:

- Support the maintenance and enhancement of Corporate Regulatory policies and procedures
- Assist in collecting and organizing information on Regulatory SharePoint And TEAM sites as needed
- assist with the collection of labels and product information needed for the submission of UDI information to the FDA and Global Data Synchronization Network (GDSN) for compliance with U.S., U.K and EU UDI requirements.
- Assist senior Regulatory Affairs staff as assigned in writing, formatting, researching, compilation, cross-checking, eCopying, submitting, and generating appropriate responses to FDA requests
- Assist with the dissemination of supplier notifications for UDI, collection of responses and maintenance of documentation
- Maintain department records of medical device assessments and regulatory submissions
- Protect company confidential information by properly storing, retrieving and disseminating such information only to those authorized
- Conduct daily activities of assigned job responsibilities and projects as assigned
- Support a safe, clean and secure working environment by supporting procedures, rules and regulations
- Utilize Excel and PowerPoint to prepare and present progress reports

**The Experience, Skills and Abilities Needed**:
**Required**:

- Currently enrolled in a bachelor's degree program with a major in regulatory affairs, legal or governmental compliance matters, quality systems, internal auditing, applicable scientific, business, or technical functions and/or healthcare industry experience
- Sophomore year requirements must be completed by program start

**Other**:

- Strong learning agility, resourceful, and team-oriented
- Excellent communication skills (written and verbal)
- Analytical thinker with a high attention to detail and quality
- Ability to manage multiple responsibilities at once
- Well-organized

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.

STERIS strives to be an Equal Opportunity Employer. STERIS is committed to treating all people in a way that allows them to ‎maintain their dignity and independence. We believe in integration and equal ‎opportunity. Accommodations are available throughout the recruitment process ‎and applicants with a disability may request to be accommodated throughout the ‎recruitment process.‎ We will work with all applicants to accommodate their individual accessibility ‎needs.

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