Compliance Coordinator

At STERIS, we strive to create a healthier and safer world by providing innovative healthcare and life science solutions globally.

Job Summary

We are seeking a highly motivated Regulatory Affairs Specialist to join our team in a dynamic and collaborative environment.

The primary objective of this role is to establish and maintain efficient processes for obtaining and maintaining product clearance globally. This involves handling submissions for CE marking and identifying requirements in other markets, working closely with product teams to ensure compliance.

The Regulatory Affairs Specialist will gain in-depth knowledge of key markets and related regulations, including:

• 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 specialist will assist in various functional areas under the guidance of their manager and senior Regulatory Affairs staff.

Key Responsibilities

• Maintain compliance with Corporate Procedures and guidelines
• Adhere to STERIS Code of Business Conduct and Ethics
• Protect confidential information and maintain data integrity
• Complete assigned responsibilities and projects in a timely and efficient manner
• Maintain a safe and healthy working environment
• Assist in updating essential requirements for products and services
• Support regulatory affairs activities for products in Italian and international markets

Registration and Technical Duties

• Prepare and maintain regulatory documents and submissions
• Assist in document preparation and submission for product registration
• Monitor and maintain regulatory documents and records
• Support with RA documentation and information management
• Interact with regulatory agencies to ensure compliance and resolve issues

Education and Qualifications

High School Diploma or GED, Bachelor's Degree in Engineering, Biology, or a related field

Required Skills and Competencies

• Proficient in Microsoft Office applications and regulatory software
• Italian and English proficiency required
• Strong interpersonal skills, self-motivation, and organizational abilities
• Excellent communication and problem-solving skills

STERIS Values

We are dedicated to equal employment opportunity, ensuring fairness in hiring and promotions regardless of various factors.

STERIS is a global leader in healthcare, life sciences, and dental solutions, committed to creating a healthier and safer world.