Director, Regulatory Affairs

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 mission of the STERIS Regulatory Affairs function is to implement and support efficient and effective processes to obtain and then maintain clearance to market STERIS products in support of STERIS’s US business plans. The main product/service of focus for the Director, Regulatory Affairs are those originating from the Infection Prevention Technologies and Applied Sterilization Technologies business units. The Director of Regulatory Affairs works with product acquisition and/or development teams to ensure all applicable requirements are met. This function also identifies and supports Quality and Regulatory Compliance needs when and where applicable. In addition, the Director, Regulatory Affairs is well versed in current and pending changes in the US regulatory landscape, including all current and pending FDA guidance documents.  With this regulatory knowledge, the incumbent will drive innovation in the regulatory strategy to create market advantages for STERIS, while ensuring compliance. These activities require close work with STERIS Corporate domestic staff and leadership, significant interaction with business and Quality partners, and will include frequent interactions with FDA.

General Duties

• Provides regulatory guidance and strategic advice to Regulatory Affairs’ senior executive, business partners, and department staff. Participates in industry leadership groups such as AAMI working groups and RAPS. 
• Uses his/her influence and experience as a regulatory professional to partner with diverse functional areas of the company to bring about continuous improvement in systems, practices, and documented Corporate Procedures; solicits and evaluates suggestions from staff and others, incorporating changes as appropriate
• Assists Regulatory Affairs leadership in preparation of materials for board or committee presentations, presentations to FDA, special investigations, or other purposes as requested.
• Maintains conduct in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policies.
• Protects company confidential information by properly storing, retrieving and disseminating such information only to those authorized.
• Conducts daily activities of assigned job responsibilities and projects as assigned.
• Supports a safe, clean and secure working environment by supporting procedures, rules and regulations.

Duties

Regulatory Submissions

• Ensures that submission documents, shared folders, and databases are maintained in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory information. Maintains the top-level record of cleared submissions.
• Monitors current projects and pending and planned submissions to track timelines; identifies any unexpected delay, and communicates progress, changes, redirection or timeline changes on projects and submissions to Regulatory Affairs leadership and business partners.
• Critically reviews premarket notifications and similar packages prior to their submission to FDA, including pre-submission packets, 510(k)s, 513(g)s, de novo requests, and related responses, to ensure that each meets departmental and FDA standards for quality and integrity. Maintains a submission process consistent with STERIS procedures and current FDA guidance. 
• Is knowledgeable of, and advises the submission team on, the content and objectives of the submission, the content of responses to FDA requests and all communication with review staff.
• Develops innovative regulatory strategies to create market advantages for STERIS and ensure compliance.
• Develops new and creative regulatory strategies that broaden the market potential of products.  Partners with product development teams to support novel use cases or registration pathways.  
• Maintains awareness of new regulations and guidance documents applicable to STERIS products or services; develops new tactics to leverage regulation changes, proposes comments to draft guidance or standards in support of STERIS position as applicable, or plans specific actions to ensure compliance. 
• Ensures that a documented Regulatory Strategy is available to the project team for each development project and that requirements are clearly defined and rationales provided for recommendations. Engages Regulatory Affairs management and business partners as necessary when changes occur or new opportunities, risks or requirements are identified, and proposes appropriate actions. 
• Reviews, advises or consults on, and approves printed and web-based product labeling and marketing/promotional/technical literature to ensure that all lab