We are currently hiring for a Medical Device Regulatory Compliance Manager to be based in our Dublin office. This role is reporting to the Quality Director QP Importation Operations.
This is a Permanent position.
The Medical Device Regulatory Compliance Manager ensures that supply chain processes in place to meet global regulatory requirements for medical devices. As the Legal Manufacturers representative, this role is directly responsible for managing regular external authority inspections of the Legal Manufacturer processes. These inspections are required to maintain certification that enables medical devices to be placed on the market.
- As Medical Device Regulatory Compliance Manager you will:
- Manage interactions and communications with external regulatory authorities for the PSC medical devices, i.e. Competent Authorities and Notified Bodies, to register and maintain medical device filings
Operate quality system processes to maintain appropriate external certification for PSC medical devices
- Ensure a compliant operation is in place for Pharma Supply Chain medical devices
- Manage governance processes for Medical Device supply chains, including incident management, Quality Council and risk management
- Manage self-inspection activities and CAPA management processes covering Medical Device Team operations to support maintenance of certifications
- Ensure the Medical Device Team and associated supply chain is inspection ready and lead/host external inspections of the Legal Manufacturer
- Coordinate supply chain processes for medical devices
- Review and approve appropriate batch verification, change controls, and artwork changes relating to supplied medical devices
- Ensure deviations during production have been adequately investigated by the manufacturer and are trended, with appropriate CAPA identified
- Ensure customer complaints are coordinated and suitable technical assessment conducted
- Ensure device technical files are maintained and post-marketing surveillance processes are followed so that periodic safety update reports are completed in accordance with regulatory requirements
- Act as QMS Champion for Medical Device Team and provide oversight for QMS implementation so that companies policies are assessed and implemented as required.
- Support QMS activities across the wider QP Importation Hub
Experience and Education Requirements:
- Science or engineering degree and significant experience in pharmaceutical / medical device manufacturing and quality operations.
- Excellent working knowledge of quality system requirements.
- Experience in quality and compliance within a manufacturing and / or development environment for medical device / pharmaceutical product supply.
- Excellent knowledge of GMP / medical device regulations.
- Demonstrated skill in managing multiple priorities.
- Experience of batch verification processes.
- Excellent oral and written communication skills.
- Capable of working in multi-disciplinary teams across Quality, External Supply, Supply Chain, Regulatory, Clinical Safety and Medical, Technical, IT and Manufacturing
- Demonstrated ability to function effectively in a matrix organisation.
Ability to influence and negotiate at senior levels across functional boundaries.