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 SummaryWe are looking for a Regulatory Affairs Intern to join our team base in Pomezia (Roma).
The mission of the STERIS Regulatory Affairs function is to implement efficient and effective processes to initially obtain and then maintain clearance to market STERIS products in support of STERIS's global business plans.
This includes determining submission to NB for the CE marking and in some cases of registration and/or submission requirements in the International markets, working with STERIS International Registration staff to identify requirements in other targeted markets, and working with product acquisition or development teams to ensure these requirements are met.The Regulatory Affairs Intern will develop a working knowledge of the following market and the regulations and standards associated:European Union: Medical Device Directive 93/42/EC as amended by 2007/47/ECEU MDR Regulation 2017/745Key International Standards:ISO 13485: Medical devices – Quality management systemsISO 9001: Quality management systemsISO 14971 Application of Risk Management to Medical DevicesThe Regulatory Affairs Intern will have responsibility to support the duties of the functional areas described below, as assigned, under the guidance and direction of his/her manager and other senior Regulatory Affairs staff.General DutiesResponsible for maintaining understanding of and compliance with all current active Corporate Procedures applicable to his/her job functionsMaintain conduct in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policiesProtect company confidential information by properly storing, retrieving, and disseminating such information only to those authorizedConduct daily activities of assigned job responsibilities and projects as assignedSupport a safe, clean and secure working environment through adherence to applicable procedures, rules and regulationsAssist in the updating and maintenance of essential requirements and GSPR checklists and technical files for products sold into the EU market.
Assist to complete change control documentation for regulatory related product changesSupport in the execution of regulatory affairs and compliance activities for company product lines in both the Italian and international markets in which the Company conducts businessRegistration and Technical DutiesSupport in the preparation, monitoring and maintenance of documents for any submissions to NB and shared drive folders, and databases in an accurate, complete and timely manner to ensure prompt and accurate access to company regulatory informationAssist in the preparation, compilation, and submission of regulatory documents for the registration of current and new products in some marketsAssist in Monitoring and maintenance of regulatory documents to keep the CE markingSupport local commercial and tender offices with RA documentation/informationInteract with Regulatory Affairs personnel at regulatory agencies, including NB, consultants, contract manufacturers, and distributors to ensure requirements are understood and submissions are complete and accurate to avoid any potential delays in approvalEducation DegreeHigh School Diploma or GEDBachelor's Degree in Engineering General or BiologySpecific Work RequirementsExcellent PC skills, including Microsoft Office applicationsItalian mother tongue and English fluent are mandatoryStrong interpersonal skills – ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective action; able to work effectively and professionally with external people including Customers and government officialsSelf-starter that is highly organizedStrong oral and written communication skills.Additional InformationWe are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, sex, sexual orientation, gender identity, genetic information, and any other category protected by state or local law.STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention.
STERIS strives to be an Equal Opportunity Employer.
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