Regulatory Affairs Specialist (Mentor, OH, US, 44077)

Steris Corporation•Mentor, OH

46d•$55,000 - $62,250•Hybrid

About The Position

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 Reporting to the Lead, Regulatory Affairs Specialist (or Manager, Regulatory Affairs) within the RA Department, the incumbent is responsible for supporting the development and administration of STERIS's global regulatory policy positions across product lines of the STERIS businesses by preparing international regulatory submissions for the full range of STERIS product approvals. The Incumbent will also provide support for plans to achieve identified corporate regulatory policy objectives. Responsible for keeping abreast of and providing regular reporting to key business leaders on key regulatory developments that impact customers, or STERIS's business directly. This is a hybrid role with the requirement of working onsite at our Mentor, Ohio Corporate HQ.

Requirements

Bachelors Degree
1+ years' experience in a professional office or administrative setting, preferably within a regulated industry (e.g., pharmaceuticals, medical devices, biotech)
Experience supporting documentation processes, including reviewing or organizing files
Experience preparing or reviewing submission materials for regulatory agencies (even in an academic or internship setting)
Proficiency in Microsoft Office programs-specifically Word (document formatting), Excel (basic data entry and tracking), and PowerPoint (presentation support), MS Teams
Basic familiarity with Oracle, including navigation and data entry
Strong attention to detail, organizational skills, and ability to manage multiple tasks with minimal supervision

Nice To Haves

Experience includes working with ISO 13485 standard and regulatory frameworks for medical devices or chemical-based products is preferred
Familiarity with international regulatory markets, particularly in LATAM, EU, and APAC regions, is a plus
Spanish is a valued asset for supporting global regulatory activities, but not required
Exposure to regulatory or quality systems, such as document control or compliance tracking tools
Experience working in a team-based environment with cross-functional collaboration, as well as the ability to work independently

Responsibilities

Identify regulatory requirements for new products or product enhancements early in the product development cycle.
Gather information to support regulatory submissions. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims.
Review product revision requests to assure compliance with regulatory requirements.
Work on product teams to develop regulatory strategy based on regulatory submission requirements.
Review and approve labeling and marketing literature.
Support Lead Regulatory Affairs Specialist (or Manager, Regulatory Affairs) and other Regulatory Affairs staff with all regulatory matters.
Work with direct Supervisor and senior internal stakeholders to identify key initiatives, which may be affect by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management.