Regulatory Affairs Manager - Medical Device

Industry: Lifescience Industry: Medtech, Digital Health

Employment Type: Full-time

Job Functions: Regulatory Affairs

Location: Meditrial, Via Po 9 Rome, Italy

Workplace: Office-based / availability to travel

The Regulatory Affairs Manager oversees the regulation process for products (Medical Device and Marketing Authorization) requiring governmental approval, including filing necessary applications and handling all government interactions. The position will ultimately support and/or drive strategic regulatory strategies for multiple projects together with the subject matter experts. Coordinates inspections of the organization and contract facilities, and develops procedures to ensure regulatory compliance pre and post-market.

Responsibilities

• Collaborate during implementations of regulatory strategies for Medical Devices through National/Decentralized/Centralized Procedures
• Collaborate during the Technical File (TF) creation and any updates
• Support the management of clinical investigations, drafting and reviewing essential documentation including clinical investigation protocols
• Manage the Medical Device Post-marketing and Surveillance Medical Devices activities
• Supervise International Regulatory and Quality activities
• In addition to the above activities, the role can be asked to carry out tasks related to the belonging function or that may result from business needs

Qualifications

Education: Master’s Degree in science or related field; Doctor of Medicine (MD) is a plus.

Thorough experience in life-science field and Regulatory Affairs.

Languages: Proficiency in oral and written English and Italian (third language is a plus).

Proficient in Microsoft Office (MS Outlook, MS Word, MS Excel, MS PowerPoint).

Excellent communication, planning, and organizational skills.

Demonstrated ability to handle multiple competing priorities.