Health

Head of Medical Device - Regulatory Affairs

Reference Number: SM239

Job Type

Full Time

Availability

Permanent

Head of Medical Device – Regulatory Affairs

Are you a seasoned professional in medical device regulatory affairs looking for a leadership role? Our client, a leading company in the medical devices industry, is seeking a Head of Medical Device Registered Person to join their team in Malta!

Key Responsibilities:

Regulatory Compliance: Ensure company compliance with applicable Medical Devices Regulations, local legislations, and regulatory agreements with manufacturers or suppliers.
Quality Management System (QMS): Design, set up, and maintain an effective QMS for medical devices to ensure regulatory compliance and product quality.
Inventory Management: Implement and oversee an adequate inventory management system and efficient record-keeping to ensure traceability of medical devices.
Good Distribution Practice (GDP) Guidelines: Ensure compliance with GDP guidelines, including premises and equipment suitability, personnel training, storage conditions, and pest control.
Importer and Distributor Procedures: Design and establish procedures in line with the roles and responsibilities of an importer and distributor of medical devices.
Regulatory Documentation: Compile and maintain a database of records as required by EU regulations.
Complaint Handling: Manage product return requests and notifications to local authorities, and report product complaints within specified timelines to manufacturers or suppliers and local authorities.
Post-Market Surveillance: Assist in implementing corrective actions necessitated through post-market surveillance and handle Field Safety Corrective Actions and recalls related to medical devices.
Supplier Qualification: Handle qualification of service suppliers related to medical devices to ensure quality and regulatory compliance.
Internal Audits: Perform internal audits of relevant areas to identify areas for improvement and ensure compliance with regulations and standards.
Inspections and Audits: Host inspections and audits from local authorities and suppliers related to medical devices.
Team Development: Train, monitor, and develop present and future team members to meet their work objectives.
Regulatory Guidelines: Stay informed about guidelines issued by regulatory authorities such as the Malta Medicines Authority and EU authorities, and ensure compliance with them.

Skills and Qualifications:

Bachelor’s degree or higher in a life science. Qualified Pharmacists suitably registered and licensed to practice in Malta and who can act as deputy Responsible Person (RP) will be given preference.
Be duly registered as MDRP with the Malta Medicines Authority (MMA).
Minimum 1 year of professional experience in Regulatory Affairs or in quality management systems related to medical devices.
Excellent verbal and written communication skills.
Be conversant in all Microsoft Office applications.
Be a team player.
Be self-disciplined and able to work to strict deadlines.