Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist

Job Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at STERIS. As a Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with regulatory requirements and maintaining the quality and safety of our products.

Key Responsibilities:

• Maintain a thorough understanding of regulatory requirements and industry standards, including the EU MDR Regulation 2017/745 and ISO 13485:2016.
• Develop and implement regulatory strategies to support product development and commercialization.
• Collaborate with cross-functional teams to ensure regulatory compliance and quality standards.
• Prepare and submit regulatory documents, including technical files and GSPR checklists, to support product registrations.
• Monitor and maintain up-to-date knowledge of regional and national regulations, guidelines, and advisory documents.

Requirements:

• Bachelor's Degree in Biological Science or related field.
• Excellent PC skills, including Microsoft Office applications.
• Italian mother tongue and English fluent.
• International regulatory experience.
• Ability to work closely with people at all levels within the STERIS organization.

About STERIS: STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. We 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.