EU Regulatory Manager - Medical Devices
Summary of Key Responsibilities and Role
The European Regulatory and Quality Manager will report to the Director Regulatory and Clinical Strategy.
The role will have management and tactical responsibility for the maintenance and continuous improvement of the company quality policy and adherence to ISO13485.
The role will manage the European Regulatory strategy and day to day implementation of its objectives.
Responsibilities - Regulatory
, Manage the European regulatory function in relation to both product certification and company compliance
, Prepare regulatory submissions within the EU
, Maintain technical files by product and ensure appropriate data is captured during the product development life cycle and is kept current
, Work closely with and be primary contact for European competent authority
, Work with various distribution partners to provide input and information as needed to ensure local regulatory submissions are made and local approvals gained as needed
, Ensure European regulatory activities are aligned with business priorities
, Review labelling and packaging components to ensure accuracy and compliance with various regional regulations
Responsibilities - Quality
, Own, challenge and continuously improve the existing quality system.
, Ensure all documents and procedures are in place and kept current and relevant to quality scope, i.e.
design development and manufacture of medical devices.
, Be the management representative for all audits and manage the company quality management system (currently ISO 13485) and any other accreditations required, ensuring compliance with regulatory requirements and workmanship standards.
, Oversee the corrective and preventive action process, coordinating CAR root causes and corrective actions for both in-house and customer returns (RMA) and complaints, with follow up checks to verify implementation.
, Management of supplied material quality issues.
Working with suppliers to ensure issues are effectively resolved and investigations are fully documented.
Instigate and implement effective corrective and preventative actions (CAPA).
, Own quality for the supply chain and manufacture and ensure that processes, practices and records are effective to ensure the end quality of our products is to specification.
, Be proactive to ensure changes to the relevant standards are adopted in a timely manner.
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