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Head of Regulatory Affairs and Quality Management
Project duration: 4 years, 8 months
Brief description
An internationally operating manufacturer of Class IIb active medical devices has been advised to regain process compliance. Because of the success of the activity, the manufacturer decided to transfer the position of Head of Regulatory Affairs and Quality Managment on a mandate basis.
Supplement
Quality management representative of the company with direct report to the management. Head of the Quality and Regulatory Affairs Department. Continuous analysis and further development of the QMS and the associated internal processes. Responsible for deviation and complaint management (PMS and vigilance system, CAPA). Responsible for product approvals in international markets.
Subject description
Strategic advice to the management on regulatory issues. Ensuring compliance with international quality standards and specific regulatory requirements (in particular EN ISO 13485, 14971, 62304, 62366, 60601 and their supplementary standards; MDD; MDR). Continuous updating and streamlining of the quality management system (e.g. adaptation to EN ISO 13485:2016, EU 2017/745 (MDR). Transfer of medical device files in accordance with MDR requirements. Preparation, execution and follow-up of internal audits (or delegation) as well as external audits (Notified Body and authorities).
Overview
- Industries medical technology
- DV tasks project management
- System environment PC systems/networks
- Procedure model customer standard
Project period02.02.2015 - 30.09.2019
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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