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Regulatory Compliance Trainee
2 mesi fa
At STERIS, we are dedicated to enhancing global health through innovative healthcare and life science solutions.
Position Overview
We are on the lookout for a Regulatory Compliance Trainee to become a vital part of our team.
The mission of the STERIS Regulatory Affairs team is to streamline processes for acquiring and sustaining product approvals on a global scale. This includes managing submissions for CE marking and understanding requirements in various markets, collaborating closely with product teams to ensure adherence to regulations.
The Regulatory Compliance Trainee will acquire insights into significant markets and their corresponding regulations, which include:
- Europe/Middle East/Africa (EMEA): Medical Device Directive 93/42/EC, EU MDR Regulation 2017/745
- Key International Standards: ISO 13485, ISO 9001, ISO 14971
The trainee will support multiple functional areas under the mentorship of their supervisor and experienced Regulatory Affairs professionals.
Key Responsibilities
- Ensure compliance with Corporate Procedures
- Follow the STERIS Code of Business Conduct
- Safeguard confidential information
- Complete assigned tasks and projects
- Maintain a safe working environment
- Assist in updating essential product requirements
- Support regulatory affairs initiatives for products in both domestic and international markets
Registration and Technical Responsibilities
- Prepare and manage regulatory documentation
- Assist in the preparation and submission of documents for product registration
- Monitor and maintain regulatory files
- Support with Regulatory Affairs documentation and information
- Engage with regulatory bodies to ensure compliance
Educational Background
High School Diploma or GED, Bachelor's Degree in Engineering or Biology preferred.
Specific Work Requirements
- Proficient in Microsoft Office Suite
- Fluency in Italian and English is essential
Required Competencies
- Strong interpersonal abilities, self-motivated, well-organized
- Exceptional communication skills
Additional Information
We are committed to equal employment opportunities, ensuring fairness in hiring and promotions without regard to various factors.
STERIS stands as a leading global provider of healthcare, life sciences, and dental solutions. We are on a mission to foster a healthier and safer world. Join us in this endeavor.
STERIS is an Equal Opportunity Employer.