The Regulatory Affairs and Quality Assurance Manager is responsible for establishing the Company’s regulatory and quality assurance plan to ensure developed products achieve market approval in all major commercial markets such as USA, Europe and Asia.
The Manager will ensure the Company is operating under an approved Quality Management System that meets both regulatory requirements and operational requirements for the Company to execute on its development plan in an efficient manner.
They will play a key role in developing the Company’s commercial strategy as the key architect on determining and negotiating with regulatory bodies the most rapid route to market.
You will report to the Global Site Leader.
Responsibilities
Lead the development of regulatory strategy to achieve market approval in Europe, USA and Asia. The Company has a “Europe first” strategy for commercialization.
Develop the Quality Management System (QMS) and interface with notified bodies to properly plan and pass quality audits, assembly and submission of the Company’s technical file and/or design dossier for CE Mark approval.
Guide and Audit the Company on its maintenance of the QMS identifying areas of variance in a timely fashion so that corrective action is made to keep the Company in compliance with the QMS.
Advise R&D on the regulatory impact of material selection, product design and classification and the regulatory/product approval impact of specific product design revisions.
Keep abreast of all new regulatory and quality guidelines and approval requirements for competitive technologies or “similar” risk products in the Company’s area of focus.
Interface with the Company’s Clinical Research Organization (CRO) to ensure all clinical data, reporting of adverse events, and monitoring visits are being done in a timely fashion to meet both Competent Authority and Notified Body requirements.
Prepare the Company’s technical file and/or design dossier for submission to the Notified Body for CE approval and prepare the Company for all Notified Body inspections.
Liaise with US regulatory consultants to develop a clear US road map to approval.
Liaise with European reimbursement consultants and CMS in the USA to recommend the most immediate and efficient pathways to product reimbursement.
Requirements:
A minimum of 10-15 years experience in the regulatory and quality field at the manager or director level having responsibility for CE market approval.
Demonstrated ability for establishing and maintaining a Quality Management System having prepared for and passed quality inspections from a recognized Notified Body.
Experienced project management skills and the ability to develop and execute a plan to achieve CE Mark.
Risk management skill and experience in working with medical device engineers on how to set up and document the design and development process to ensure all work completed is documented and valid to support market approval.
Clinical trial management experience and database management.
Package:
Permanent fulltime position
Salary
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Job Description
The Regulatory Affairs and Quality Assurance Manager is responsible for establishing the Company’s regulatory and quality assurance plan to ensure developed products achieve market approval in all major commercial markets such as USA, Europe and Asia.
The Manager will ensure the Company is operating under an approved Quality Management System that meets both regulatory requirements and operational requirements for the Company to execute on its development plan in an efficient manner.
They will play a key role in developing the Company’s commercial strategy as the key architect on determining and negotiating with regulatory bodies the most rapid route to market.
You will report to the Global Site Leader.
Responsibilities
Lead the development of regulatory strategy to achieve market approval in Europe, USA and Asia. The Company has a “Europe first” strategy for commercialization.
Develop the Quality Management System (QMS) and interface with notified bodies to properly plan and pass quality audits, assembly and submission of the Company’s technical file and/or design dossier for CE Mark approval.
Guide and Audit the Company on its maintenance of the QMS identifying areas of variance in a timely fashion so that corrective action is made to keep the Company in compliance with the QMS.
Advise R&D on the regulatory impact of material selection, product design and classification and the regulatory/product approval impact of specific product design revisions.
Keep abreast of all new regulatory and quality guidelines and approval requirements for competitive technologies or “similar” risk products in the Company’s area of focus.
Interface with the Company’s Clinical Research Organization (CRO) to ensure all clinical data, reporting of adverse events, and monitoring visits are being done in a timely fashion to meet both Competent Authority and Notified Body requirements.
Prepare the Company’s technical file and/or design dossier for submission to the Notified Body for CE approval and prepare the Company for all Notified Body inspections.
Liaise with US regulatory consultants to develop a clear US road map to approval.
Liaise with European reimbursement consultants and CMS in the USA to recommend the most immediate and efficient pathways to product reimbursement.
Requirements:
A minimum of 10-15 years experience in the regulatory and quality field at the manager or director level having responsibility for CE market approval.
Demonstrated ability for establishing and maintaining a Quality Management System having prepared for and passed quality inspections from a recognized Notified Body.
Experienced project management skills and the ability to develop and execute a plan to achieve CE Mark.
Risk management skill and experience in working with medical device engineers on how to set up and document the design and development process to ensure all work completed is documented and valid to support market approval.
Clinical trial management experience and database management.
Package:
Permanent fulltime position
Salary
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical