Regulatory Affairs Specialist – Temporary

This is a fully remote position, open to applicants in Italy.

📋 Description

• Provide regulatory insights for the development of new products and planning throughout the product lifecycle, primarily for the Global Surgical Solutions product range (Operating Lights, Operating Tables, and Accessories).

• Generate documentation and procedures related to product development, manufacturing, and quality control, ensuring adherence to regulatory standards.

• Ensure compliance with regulations (e.g., 21 CFR 820, MDR), standards (ISO 13485), and internal quality manuals and procedures.

• Collaborate closely with product development, clinical, and marketing teams to gather necessary information for new product submissions and offer regulatory guidance to project teams as needed (e.g., DHF/Technical Documentation maintenance).

• Review various documents, including Clinical Evaluation Reports, risk analysis, FMEA reports, labeling, advertising, promotional materials, and marketing literature.

• Assist in document control, including the review, approval, archiving, and maintenance of document lists, while collaborating with other functional groups to develop new processes or procedures.

• Maintain regulatory files in accordance with established requirements.

• Evaluate the acceptability of quality, preclinical, and clinical documentation for regulatory submission filings.

• Monitor applications that are under regulatory review.

• Communicate the progress of applications to internal stakeholders.

• Relay preapproval compliance activities.

• Ensure adherence to post-marketing approval requirements for products.

• Verify that external communications comply with regulations.

• Identify potential emerging issues related to Regulatory Compliance.

• Provide regulatory input for product recalls, recall communications, and CAPAs when necessary.

• Offer MDR updates and guidance to product development teams.

⛳️ Requirements

• A completed academic degree in a relevant medical, science, engineering, or regulatory discipline is required.

• A minimum of 1-2 years of experience in creating and managing international regulatory submissions for Medical Devices (Class I & II preferred), or over 5 years in the medical device industry or a related GMP environment, or equivalent experience.

• Specific experience with medical devices, particularly those developed for Class I and Class II hardware.

• Experience with Global Registration for Medical Devices.

• Initial Project Management experience, ideally supporting new product developments and launches.

• Strong proficiency in Microsoft systems (Excel, PowerPoint, Word, Teams, SharePoint, Copilot).

• Exceptional attention to detail, accompanied by strong questioning and listening skills.

• Effective planning and organizational skills with the capability to track and manage complex information.

• Analytical and problem-solving capabilities.

• A strong focus on internal customer service, demonstrating a “do whatever it takes” attitude.

• Excellent communication skills in English.

• Ability to collaborate in cross-functional teams with individuals from various disciplines and cultures.

• Experience in reviewing technical documents.

🏝️ Benefits

• Health insurance.

• 401(k) matching.

• Flexible working hours.

• Paid time off.

• Opportunities for professional development.