STERIS CORPORATION Hiring for Regulatory Affairs Specialist at Mentor, Ohio Full Time

Job Title: Regulatory Affairs Specialist Req ID: 25184 Job Category: Regulatory Affairs Mentor, OH, US, 44060 Description: 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 SummaryReporting to the Lead Regulatory Affairs Specialist within the RA Department, the Regulatory Affairs Specialist 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. This role will also provide support for plans to achieve identified corporate regulatory policy objectives. You will also be 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.DutiesIdentify 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 and other Regulatory Affairs staff with all regulatory matters.Work with Lead Regulatory Affairs Specialist 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.Prepare and / or review written materials for substance and / or policy consistency.Required ExperienceA Bachelor’s Degree plus a minimum of 3 years’ previous government relations and regulatory experience.Government agency and / or legislative experience required.Some understanding of chemical / medical device industry, in particular the workings of the regulatory and legislative environment around the world.Comprehension of industry developments and changes in the political environment.Demonstrated excellence in the following: communication skills, listening skills, interpersonal skills, cross BU team coordination, planning, research, diplomacy, advocacy and sales skills.Ability to operate in a business devein model providing quick, salient analysis and concrete action plans with emphasis on understanding and anticipating business needs and interests, and devising proactive approaches / responses.#LI-NB1STERIS is a leading provider of products and services that meet the needs of growth areas within Healthcare: procedures, devices, vaccines and biologics. We exist to fulfill our MISSION TO HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD. STERIS is a $3B, publicly traded (NYSE: STE) company with approximately 16,000 associates and Customers in more than 100 countries.If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.STERIS is an Equal Opportunity Employer. We are committed to equal employment opportun