Regulatory Affairs Specialist
3 settimane fa
At STERIS, we strive to create a healthier and safer world by providing innovative healthcare and life science solutions.
Position Overview
We are seeking a highly organized and detail-oriented Regulatory Affairs Intern to support our team in Pomezia, Italy.
The Regulatory Affairs function at STERIS is responsible for implementing efficient processes to obtain and maintain clearance to market our products globally. This includes determining submission requirements for CE marking and international markets, working with registration staff to identify requirements, and collaborating with product development teams to ensure compliance.
The successful candidate will develop a working knowledge of European and international regulations, including the Medical Device Directive and EU MDR Regulation. They will assist in maintaining essential requirements and GSPR checklists, as well as supporting the execution of regulatory affairs and compliance activities for our product lines.
Key Responsibilities
- Support the preparation and maintenance of documents for submissions to regulatory agencies
- Assist in the preparation and submission of regulatory documents for product registration
- Monitor and maintain regulatory documents to ensure CE marking
- Interact with regulatory agencies and external stakeholders to ensure requirements are understood and submissions are complete
Requirements
- High school diploma or equivalent required; 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
We are committed to equal employment opportunity and affirmative action programs to ensure diversity and inclusion in our workforce.
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