Manager, Regulatory Operations

STERIS Corporation•Mentor, OH

4h•$95,000 - $115,000•Hybrid

About The Position

The Manager, Regulatory Operations manages staff and activities that standardize and optimize regulatory operations in support of STERIS’s global business plans. The role focuses on FDA registration and listing requirements for medical-device manufacturing sites, labeling review, global Unique Device Identification (UDI) submissions, integration projects, and business continuity. The position works closely with domestic and international STERIS staff, customers, and U.S. and foreign government agencies, as well as partners across Regulatory, Quality, Regulatory Compliance, and affected business areas. The role requires working knowledge of the listed U.S. and international regulations and standards, including FDA requirements for medical devices and pharmaceuticals, quality management systems, sterilization, risk management, EU medical-device requirements, and UDI guidance. The manager supports the collection, management, and submission of product information to the STERIS UDI System and develops and maintains corporate regulatory policies, procedures, and work instructions. This is a hybrid role requiring onsite work at STERIS’s Mentor, Ohio Corporate Headquarters three days per week. The stated pay range is $95,000–$115,000, with eligibility for bonus participation. The position is open until filled.

Requirements

Bachelor’s degree required; preferably with a scientific, engineering, regulatory, internal audit, or general business concentration.
At least 5 years of experience in regulatory work, preferably in medical devices and/or pharmaceuticals.
Excellent PC skills, including Microsoft Office applications.
Experience working on cross-functional teams.
Previous experience leading or overseeing work, or in project management.
Experience assigning and delegating tasks and holding employees accountable for timelines.
Demonstrated ability to balance multiple high-priority responsibilities and complete them on time and effectively.
Self-starter with organizational, project-management, time-management, and problem-solving skills.
Strong interpersonal skills and ability to work professionally with people at all organizational levels, customers, and government officials.
Strong oral and written communication skills.
Working knowledge of the regulations and standards listed in the posting, including FDASIA; applicable 21 CFR parts; ISO 13485, ISO 9001, EN ISO 11135-1, EN ISO 11137-1, ISO/IEC 17025, and ISO 14971; EU medical-device requirements; and UDI guidance.

Nice To Haves

Professional certifications and regulatory training certificates in relevant disciplines.
Completion of or active progress toward an advanced degree in a relevant discipline.
Bilingual skills.
Experience with risk management.
Professional experience in regulatory affairs, legal or governmental compliance, quality systems, internal auditing, relevant scientific, business, or technical functions, and/or the healthcare industry.
Experience registering drugs, human cell tissue, or medical devices, and/or familiarity with contract sterilization processes.

Responsibilities

Manage, train, utilize, and supervise Regulatory Operations staff reporting to the manager.
Work with Regulatory, Quality & Regulatory Compliance, and affected business partners to update corporate procedures in response to regulatory changes and recommend improvements to internal controls.
Communicate gathered data and results to team members and develop best practices.
Set goals, guide project activities, track progress, report status, and address setbacks to prevent delays, late filings, or disruption in product availability.
Report project status to management and identify and act on changes, delays, or risk areas.
Support implementation of a process to collect, manage, and submit product information to the STERIS UDI System via XML files.
Create, maintain, and enhance corporate regulatory and global work-instruction policies and procedures.
Work with people across STERIS and external customers and government officials, and facilitate corrective-action implementation.
Assist in developing regulatory policies and procedures, including the policy development and approval process.
Assist with investigating and researching compliance issues and ensure assigned remediation tasks are completed on time.
Assist with regulatory and compliance projects, including audit support, integration, and product relocation.
Focus on FDA registration and listing requirements for medical-device manufacturing sites, labeling review, global UDI submissions, integration projects, and business continuity.