Manager, Regulatory Operations

Position Summary The mission of the STERIS Regulatory Operations function is to standardize and optimize regulatory activities in support of STERIS’s global business plans. This includes: identification and management of global labeling and UDI requirements; determining registration and listing requirements in the US and working with STERIS facilities, customers and suppliers to comply with these requirements; supporting traffic partners and regulators to resolve import/export issues; working with STERIS International Regulatory staff to identify requirements in other targeted markets; working with product acquisition and development teams to ensure regulatory requirements are met; and administering assigned corporate compliance activities such as document control, drug/device master files, translation services and other processes as identified. This is a hybrid role with the requirement of working onsite at our Mentor, OH Corporate HQ, 3 days per week. As a Manager Regulatory Operations you must have working knowledge of the following regulations and standards: Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) 21 CFR Part 801 – Medical Device Labeling 21 CFR Part 803 – Medical Device Reporting 21 CFR Part 806 – Medical Device Corrections and Removals 21 CFR Part 807 – Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices 21 CFR Part 820 – Medical Device Quality System Regulations (QSR) 21 CFR Part 7 – Enforcement Policy, Subpart C – Recalls 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP) 21 CFR Part 11 – Electronic Records, Electronic Signatures ISO 13485 Medical devices – Quality management systems ISO 9001 Quality management systems – Requirements EN ISO 11135-1 Sterilization of healthcare products – Ethylene Oxide EN ISO 11137-1 Sterilization of healthcare products – Radiation ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories ISO 14971 Application of Risk Management to Medical Devices EU Medical Device Directive and EU Medical Device Regulation EU MEDDEV 2 12-1: Guidelines on a Medical Device Vigilance System Global Unique Device Identification Database (GUDID) Guidance for Industry International Medical Device Regulators Forum (IMDRF) Final Document: Unique Device Identification (UDI) of Medical Devices, December 9, 2013 In this role you will work closely with STERIS corporate domestic and international staff and Customers and U.S. and foreign government agencies. As a Regulatory Operations Manager you will focus on FDA registration and listing requirements for medical devices of STERIS manufacturing sites, labeling review, global Unique Device Identification (UDI) submissions, integration projects and ensure business continuity. What You'll do as a Manager, Regulatory Operations Responsible for the effective management including the training, utilization and supervision of Regulatory Operations staff reporting to the Manager. Work with others in Regulatory, Quality & Regulatory Compliance, and affected business partners to update established Corporate Procedures to accommodate the changes in regulations; recommends opportunities to strengthen the internal control structure. Responsible for effectively communicating with team members the results of data gathered and creating best practices. Set goals, guide project activities, track progress, report status as appropriate, and take action on unexpected setbacks to avoid delays, late filings, or disruption in product availability. Report regularly to management concerning project status, identifying and taking action on any unexpected changes, delays, or risk areas. Support and participate in the implementation of a new process for the collection, management, and submission of product information to the STERIS UDI System (SUS) via XML files. C…

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