Sr. Associate I, Regulatory Operations (1 Year Contract)

Buscojobs; Lombardia; In loco; EUR 35.000 - 45.000; Tempo pieno

Descrizione del lavoro

A leading medical device company is looking for a Sr. Associate I in Regulatory Operations in Milano. The role involves supporting regulatory compliance for medical devices, maintaining documentation, and adhering to quality standards. Candidates should have a Bachelor's degree in a related field and at least 1 year of Regulatory Affairs experience, alongside proficiency in English and Italian.

Servizi

Comprehensive benefits package

Opportunity to acquire international experience

Collaborative culture

Competenze

• Minimum 1 year of experience in Regulatory Affairs of Medical Devices.
• Nice to have knowledge of Italian Promotion Material regulation and local Health Authority Database.
• Proactive and flexible attitude.

Mansioni

• Support regulatory compliance for EMEA Alcon Dry Eye and Ocular Health products.
• Maintain databases of submissions and approvals.
• Ensure adherence to GxP regulations and Standard Operating Procedures.

Conoscenze

English proficiency

Italian proficiency

Knowledge of EU Medical Device Regulations

Knowledge of Pharma Regulation

Collaborative

Business oriented

Formazione

Bachelor's degree in science related

Descrizione del lavoro

Overview

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us?

This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Sr. Associate I, Regulatory Operations (Professional Path) is primarily responsible for supporting regulatory compliance for the EMEA Alcon Dry Eye and Ocular Health product portfolio. You will contribute to product notifications and submissions and collaborate with affiliate offices to address manufacturing quality assurance and health authority inquiries. This opportunity is a 12-month contract based in Milano office. Specifics include :

• Perform specialized tasks and conduct independent research to optimize outcomes, contributing to project goals with advanced skills in support of medical device and / or pharmaceutical products
• Handle medical device labeling, notifications and promo materials submission
• Maintain up-to-date databases of submissions and approvals
• Make decisions within the scope of assigned tasks to achieve project goals
• Adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs) and maintaining accurate and complete documentation with rigorous quality control
• Complete all required training and meet individual job requirements
• Contribute to the overall compliance of the organization and commit to continuous improvement in operations

All associates must adhere to GxP regulations by strictly following Standard Operating Procedures (SOPs), maintaining accurate and complete documentation, ensuring rigorous quality control, and completing all required training. Associates are responsible for meeting their individual job requirements and contributing to the overall compliance of the organization. Compliance with regulatory requirements and a commitment to continuous improvement are essential to our operations.

Qualifications

WE ARE SEEKING :

• Bachelor's degree in science related, preferably in Biomedical Engineering or Pharmacy
• English and Italian proficiency
• Knowledge of EU Medical Device Regulations, nice to have knowledge of Italian Promotion Material regulation and of local Health Authority Database for medical device notifications (“Repertorio”)
• Basic knowledge of Pharma Regulation is nice to have
• Experience in Regulatory Affairs of Medical Devices minimum 1 year
• Collaborative, flexible, proactive and business oriented person

How you can thrive at Alcon

• Comprehensive benefits package
• Open, friendly and collaborative culture; Work in a challenging environment with an outstanding team that will support him to achieve goals and performance
• Opportunity to acquire international experience

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