Regulatory Affairs Specialist
1 settimana fa
Job Summary
STERIS is seeking a highly motivated and detail-oriented Regulatory Affairs Intern to join our team. As a Regulatory Affairs Intern, you will play a critical role in supporting the implementation of efficient and effective processes to obtain and maintain clearance to market STERIS products globally.
Key Responsibilities
- Develop a working knowledge of regulatory requirements and standards associated with medical devices, including the European Union's Medical Device Directive and the EU MDR Regulation.
- Support the preparation, monitoring, and maintenance of documents for submissions to regulatory agencies and shared drive folders.
- Assist in the preparation, compilation, and submission of regulatory documents for product registration in various markets.
- Monitor and maintain regulatory documents to ensure CE marking compliance.
- Interact with regulatory agencies, consultants, contract manufacturers, and distributors to ensure requirements are understood and submissions are complete and accurate.
Requirements
- High School Diploma or GED; Bachelor's Degree in Engineering or Biology preferred.
- Excellent PC skills, including Microsoft Office applications.
- Italian mother tongue and English fluency required.
Competencies
- Strong interpersonal skills and ability to work effectively with external stakeholders.
- Self-starter with high organizational skills.
- Strong oral and written communication skills.
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