Regulatory Affairs Specialist

Regulatory Affairs Specialist

Company: Kerr Location: Salerno, Campania, Italy Work Model: Onsite

Kerr is seeking a dedicated Regulatory Affairs Specialist to join our team in Salerno. This is an excellent opportunity for a mid-level professional to contribute to our regulatory compliance efforts within the healthcare industry.

About the Role

The Regulatory Affairs Specialist will play a crucial role in ensuring our products meet stringent regulatory requirements. You will be responsible for the development and maintenance of essential regulatory documentation, ensuring compliance with current standards and facilitating international market access.

Key Responsibilities

• Establish and sustain CE Technical Files in accordance with regulatory requirements.
• Conduct final reviews of deliverables to ensure MDR (Medical Device Regulation) compliance.
• Gather and prepare documentation necessary for international registrations and licenses.
• Support daily business needs by ensuring regulatory documentation is up-to-date and accessible.
• Contribute to processes related to international regulatory frameworks such as MDSAP (Medical Device Single Audit Program) for markets including the US and Canada.

Requirements

• Proven experience in Regulatory Affairs, specifically within the healthcare industry.
• Strong understanding of MDR regulations.
• Experience in creating and managing CE Technical Files.
• Proficiency in preparing and organizing documentation for regulatory submissions.
• Familiarity with international registration processes and requirements.
• Knowledge of MDSAP is a plus.

What We Offer

• A challenging and rewarding role within a reputable healthcare company.
• Opportunity to work on diverse regulatory projects.
• A collaborative and professional work environment.
• Be part of a team dedicated to bringing innovative healthcare solutions to market.