Regulatory Affairs Intern

Position Summary

We are looking for a candidate that will join our team as Regulatory Affairs Intern (stage).

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. This group also identifies and supports Regulatory Compliance needs.

The Regulatory Affairs Intern will develop a working knowledge of the following market and the regulations and standards associated:

• Europe/Middle East/Africa (EMEA)
• European Union: Medical Device Directive 93/42/EC as amended by 2007/47/EC and EU MDR Regulation 2017/745

Key International Standards:

• ISO 13485: Medical devices – Quality management systems;
• ISO 9001: Quality management systems;
• ISO 14971 Application of Risk Management to Medical Devices.

The 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 Duties

• Support compliance with corporate procedures and company policies.
• Handle confidential information appropriately under supervision.
• Assist with daily tasks and assigned projects.
• Contribute to maintaining a safe and compliant work environment.
• Support updates of GSPR checklists and EU technical documentation.
• Assist with regulatory change control documentation.
• Contribute to project teams with regulatory input.
• Support regulatory requirements analysis and compliance activities.
• Assist during audits and inspections as needed.
• Support audits and inspections of the Italian facility.
• Assist in preparing and maintaining documentation for NB submissions and databases.
• Support preparation and submission of regulatory documentation for product registrations.
• Assist in maintaining regulatory documentation to ensure CE marking compliance.
• Monitor submission timelines and report potential delays.
• Support interactions with regulatory bodies and stakeholders.
• Assist in monitoring product changes and related documentation.

Education Degree

Work Requirements

• Excellent PC skills, including Microsoft Office applications
• Italian mother tongue and English fluent are mandatory
• Training course in Regulatory Affairs (preferred)

Competencies

• Self-starter that is highly organized;
• Strong 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;
• Strong oral and written communication skills.

Compensation

In line with our commitment to transparency and equal pay, we provide the following information:

• Salary Range: 800€
• NCBA: Chimica, Concia e Settori Accorpati, CONFAPI.