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.
JOB PURPOSE
The Medical Device Regulatory Compliance Manager ensures that supply
chain processes in place to meet global regulatory requirements for
medical devices. As the Legal Manufacturer?s 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 GSK policies are assessed and
implemented as required.
* Support QMS activities across the wider QP Importation Hub
WHY YOU?
BASIC REQUIREMENT:
* 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
PREFERRED REQUIREMENT:
* Demonstrated ability to function effectively in a matrix
organisation.
* Ability to influence and negotiate at senior levels across
functional boundaries.
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.
JOB PURPOSE
The Medical Device Regulatory Compliance Manager ensures that supply
chain processes in place to meet global regulatory requirements for
medical devices. As the Legal Manufacturer?s 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 GSK policies are assessed and
implemented as required.
* Support QMS activities across the wider QP Importation Hub
WHY YOU?
BASIC REQUIREMENT:
* 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
PREFERRED REQUIREMENT:
* Demonstrated ability to function effectively in a matrix
organisation.
* Ability to influence and negotiate at senior levels across
functional boundaries.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
