Regulatory Affairs Specialist
2 mesi fa
Job Title: Regulatory Affairs Specialist
Job Category: Regulatory Affairs
We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our team at STERIS. As a key member of our Regulatory Affairs function, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements in the European Union and other international markets.
Responsibilities:
- Develop and maintain a thorough understanding of regulatory requirements and standards, including the European Union's Medical Device Directive and Regulation, as well as international standards such as ISO 13485 and ISO 14971.
- Support the preparation, monitoring, and maintenance of documents for submissions to regulatory authorities and shared drive folders, and databases in an accurate, complete, and timely manner.
- Assist in the preparation, compilation, and submission of regulatory documents for the registration of current and new products in various markets.
- Monitor and maintain regulatory documents to ensure the CE marking of our products.
- Support local commercial and tender offices with RA documentation and information.
- Interact with regulatory authorities, consultants, contract manufacturers, and distributors to ensure requirements are understood and submissions are complete and accurate.
Requirements:
- High School Diploma or Bachelor's Degree in Engineering, General, or Biology.
- Excellent PC skills, including Microsoft Office applications.
- Italian mother tongue and English fluent are mandatory.
Competencies:
- Strong interpersonal skills – ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective action.
- Self-starter that is highly organized.
- Strong oral and written communication skills.
About STERIS:
STERIS is a leading provider of infection prevention and surgical solutions. We help our customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
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