Quality Assurance Regulatory Affairs Manager

The Mullings Group are delighted to be partnered with Ventripoint Diagnostics who are on an incredible trajectory, developing innovative technology in precision imaging and diagnostics for cardiac patients.

VentriPoint are dedicated to designing devices with their patients and users in mind, developing products with the highest degree of quality, fostering a culture focussed on quality each day.

We are seeking a QA/RA Leader to join the organisation. This is a hybrid role.

Responsibilities:

Regulatory Affairs

• Provide guidance and feedback to stakeholders on regulatory activities, (e.g., strategies, registration, etc.)
• Lead regulatory assessment of marketing claims and external communication.
• Communicate with responsible regulatory authorities, Registrars, and Notified Bodies.
• Conduct regulatory assessment of new products and changes made to existing products.
• Assist in preparing and compiling regulatory market submissions and related documents.
• Develop regulatory strategy for new products and implement plans to obtain FDA clearance/approvals, Health Canada licenses, CE Mark and other foreign regulatory approvals.
• Maintain regulatory compliance of Design History Files, Technical Files, and Device Master Records.

Quality Assurance

• Management Representative; responsible for implementation, governance, performance reporting, and maintenance of Ventripoint’s quality management system.
• Maintain the internal audit process as well as suppliers’ controls and audits.
• Manage preparation and implementation of new SOPs. Manage CAPAs, deviations, and out-of-specification investigations.
• Manage preparation and review of validation protocols and reports.
• Coordinate all audits, including scheduling, communication, reports, and follow-up actions.
• Ensure compliance with GMPs, and applicable regulatory requirements related to product importation, release and distribution in Canada, United States, and Europe.
• Oversee continuous improvement processes within an ISO environment.
• Maintain quality documentation and records.
• Support R&D with development and maintenance of the design history/technical files according to applicable regulatory requirements (e.g., Risk Management as per ISO 14971 and Design Controls).
• Develop global, regional, and multi-country regulatory strategy; aligning regulatory strategies to organizational strategies.
• Support the development and implementation of manufacturing processes and procedures for new product introductions.

Qualifications:

• Experience in the development, implementation, and maintenance of quality systems in an engineering and manufacturing environment and regulatory affairs for a medical device company.
• Proven track record in registrations of medical devices in Canada, the United States, and Europe. • Working knowledge and in depth understanding of a Quality Management System, and requirements of ISO 13485, Canadian Medical Devices Regulations, US FDA Quality System Regulations, and EU Medical Devices Regulations for medical device industry.
• Undergraduate degree or higher in a technical related field preferred
• Broad knowledge of medical device regulations (e.g., QSR, ISO 13485, MDSAP, etc.).
• Experience preparing regulatory submissions, license applications, registrations and other product approval documentation and demonstrated knowledge of applicable requirements and practices.
• Experience developing regulatory strategies and plans.
• Post Graduate Certificate in Regulatory Affairs or equivalent preferred.
• Ideally will have knowledge of ISO 14971, IEC 60601, IEC 62366, and ISO 10993.