MDRP (MEDICAL DEVICES RESPONSIBLE PERSON)

Job Description

About Our Client:

Our client is an established import agency and one of the leading distributors in the healthcare sector in Malta. They specialize in delivering high-quality medical devices and healthcare products to the market. With a strong commitment to compliance, quality, and safety, our client is dedicated to maintaining the highest standards in the industry. They are currently seeking an MDRP (Medical Devices Responsible Person) to join their team and ensure adherence to regulatory requirements and quality management practices.

The Role:

We are looking for a dedicated and detail-oriented MDRP (Medical Devices Responsible Person) to join our client’s team. This role is essential for ensuring compliance with medical device regulations, maintaining an effective Quality Management System (QMS), and supporting the overall regulatory affairs and quality assurance functions within the organization.

Main Duties and Responsibilities:

• Regulatory Compliance: Ensure compliance with applicable Medical Devices Regulations, local legislations, and regulatory agreements with manufacturers or suppliers.
• Quality Management System: Assist in designing and maintaining an effective QMS for medical devices.
• Inventory Management: Maintain an adequate inventory management system and efficient record-keeping system to ensure traceability.
• GDP Compliance: Ensure adherence to GDP guidelines, including training personnel and maintaining appropriate storage conditions.
• Procedure Development: Assist with the setup of procedures in line with the roles and responsibilities of an importer and distributor.
• Database Management: Compile and maintain a database of records as required by EU regulations.
• Product Validation: Engage in product validation practices through the EUDAMED portal.
• Product Notifications: Handle product notifications to local authorities.
• Return Management: Manage return requests and organize the disposal of goods/waste management.
• Complaint Reporting: Report product complaints within specified timelines to manufacturers, suppliers, and local authorities.
• Corrective Actions: Assist in implementing corrective actions through post-market surveillance.
• Field Safety: Assist in Field Safety Corrective Actions.
• Supplier Qualification: Handle qualification of service suppliers related to medical devices.
• Internal Audits: Perform internal audits of relevant areas.
• Inspections and Audits: Host inspections and audits from local authorities and suppliers.
• Additional Duties: Undertake any other duties as directed by the Head of Medical Devices and/or the Head of Regulatory Affairs.

Requirements:

• Education: Bachelor’s degree or higher in a Life Science.
• Registration: Must be duly registered as MDRP with the Malta Medicines Authority (MMA).
• Experience: Minimum of 1 year of professional experience in Regulatory Affairs or quality management systems related to medical devices.
• Skills: Effective communication and interpersonal abilities; proficiency in Microsoft Office applications.
• Attributes: Detail-oriented with strong organizational skills.

Why Join Us:

• Work with a leading distributor in the healthcare sector in Malta.
• Contribute to maintaining high standards of quality and compliance in medical devices.
• Be part of a dynamic and professional team.
• Opportunities for professional growth and development.

How to Apply:

If you meet the above criteria and are ready to take on a challenging and rewarding role, we invite you to apply. Please submit your CV and a cover letter outlining your experience and why you are the ideal candidate for this position.

Our client is committed to diversity and inclusion. We encourage applications from all qualified candidates regardless of age, gender, ethnicity, disability, sexual orientation, or religion.

Feel free to reach out if you need further modifications or additional information included in the job post.