Sr. Associate I, Regulatory Operations (1 year contract)

Alcon Italia Company; Milano; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A leading healthcare firm in Milano is looking for a Sr. Associate I Regulatory Operations. This role supports regulatory compliance for medical devices, requiring a Bachelor's degree in a related field and at least one year of experience in Regulatory Affairs. The successful candidate will maintain submissions databases and adhere to strict quality control and regulatory standards. This is a full-time position with a comprehensive benefits package.

Servizi

Comprehensive benefits package

Open friendly and collaborative culture

Opportunity to acquire international experience

Competenze

• Knowledge of EU Medical Device Regulations and Italian Promotion Material regulation is a plus.
• Basic knowledge of Pharma Regulation is beneficial.
• Experience in Regulatory Affairs of Medical Devices is required (minimum 1 year).

Mansioni

• Perform specialized tasks and conduct research to optimize project outcomes.
• Handle medical device labeling notifications and promotional materials submission.
• Maintain databases of submissions and approvals.
• Adhere to GxP regulations and Standard Operating Procedures (SOPs).
• Contribute to overall compliance and continuous improvement.

Conoscenze

English proficiency

Italian proficiency

Collaborative

Proactive

Business oriented

Formazione

Bachelor's degree in science (Biomedical Engineering or Pharmacy)

Descrizione del lavoro

Overview

At Alcon were passionate about enhancing sight and helping people see brilliantly. With more than 25000 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 :

Responsibilities

• 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

Qualifications

• 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

Work Details

• 12-month contract; based in Milano office
• Employment Type: Full-Time
• Experience: Senior IC
• Vacancy: 1

Benefits / 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