I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Job Tools
Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
Connect with me on
Hot Science Jobs
Production Operator
Dublin
Value Stream Team Leader / Production Su
Wexford
Senior Quality Engineer
Dublin
R&D Engineer
Galway
Senior R&D Engineer
Galway
Clinical Research Associate
Cork
Senior Quality Control Associate
Dublin South
Lead Project Engineer
Carlow
Production Manager
Dublin
Project Manager
Galway
Quality Control NPI Senior Associate
Dublin South
Senior R&D Engineer
Galway
R&D Engineer
Galway
Project Engineer
Cork
DeltaV Lead Automation Engineer
Tipperary
Product Development Engineer
Galway
Senior R&D Engineer
Dublin
R&D Program Manager
Dublin
Principal Engineer
Dublin
Senior QC Associate
Dublin
R&D Project Manager
Galway
R&D Manager
Connaught
MS&T Bioprocess Engineer
Meath
Senior Regulatory Specialist
Cork
Product Development Manager
Galway
R&D Director
Galway
QA Specialist (REMOTE)
Dublin
Program Manager
Galway
R&D Engineer
Galway
Mechanical Technician
Carlow
Senior Regulatory Affairs
Galway
Technical Life Cycle & Engineering M
Galway
R&D Manager
Galway
Senior Regulatory Affairs Specialist
Athlone
Quality Systems Manager
Dublin
CTO
Dublin
R&D Manager
Galway
Electronic Engineer
Dublin
Senior Quality Engineer
Dublin
R&D Engineer
Dublin
Design Assurance Engineer
Galway
R&D Manager
Galway
R&D Manager
Galway
Product Development Engineer
Dublin
R&D Manager
Connaught
Senior Quality Engineer
Leitrim
Quality Control Technician
Carlow
R&D Director
Galway
Electronic Engineering
Dublin
Product Development Engineer
Galway
Design Assurance Program Manager
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Senior Quality Assurance Systems Special
Dublin
Senior R&D Engineer
Dublin
Senior Project Manager - Process Develop
Cork
Senior Microbiologist
Dublin
Manufacturing Biotech Associate 24/7 Shi
Meath
R&D Engineer
Galway
E&I Turnover Engineer
Carlow
Biostatistician
Dublin City Centre
Manufacturing Engineer
Wexford
Senior Quality Engineer
Leitrim
Senior Associate Quality Control NPI
Dublin
Scientist (hybrid)
Meath
R&D Director
Galway
Quality Engineer
Galway
Senior Equipment Engineer
Dublin
Technical Transfer Specialist
Cork
Quality Technician
Dublin
Principal Device Engineer
Dublin
Associate Director - Global Core Labelin
Cork
Senior Equipment Design Engineer
Dublin
Senior Analytical Scientist
Cork
Laboratory Systems Lead (hybrid)
Meath
R&D Engineer
Galway
Senior Process Development Engineer
Galway
R&D Manager
Galway
Design Quality Assurance Engineer
Galway
QA Manager
Canada
Product Development Manager
Galway
R&D Manager
Galway
Senior Quality Engineer
Leitrim
Clinical Project Manager
Cork
Investigation Lead
Dublin
R&D Engineer
Galway
Maintenance Technician
Kilkenny
QA Specialist (Hybrid)
Tipperary
Senior Equipment Design Engineer
Dublin
Senior QC Microbiology (24/7 Shift)
Dublin
Cleaning Validation Engineer
Carlow
Project Manager
Kildare
Project Engineer
Cork
Product Development Engineer
Dublin
Regulatory Affairs Associate
Cork
Mechanical Design Engineer
Germany
Production Operator
Carlow
Sales/Customer Service Administrator
Clonmel
QA Engineer
Leitrim
Principal R&D Engineer
Dublin
Electronic Engineer
Dublin
R&D Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Production Operator
Meath
Design Quality Assurance Engineer
Galway
Manufacturing Project Engineer
Sligo
Electronic Engineer
Dublin
Principal R&D Engineer
Dublin
Compliance Specialist
Carlow
Senior QC 24/7 Shift
Dublin
Senior R&D Engineer
Clare
Quality Specialist
Dublin
Senior Regulatory Affairs Specialist
Athlone
Senior Technical Transfer Engineer - Hyb
Carlow
R&D Engineer
Galway
Principal Engineer
Dublin
Senior Engineering Manager
Limerick
Principal R&D Engineer
Galway
Sr. Associate - Quality for Computer Sys
Cork
Process Safety Specialist
Tipperary
Design Quality Assurance Engineer
Galway
R&D Engineer
Galway
Process Engineer
Galway
R&D Manager
Connaught
Product Development Engineer II
Athlone
R&D Manager
Galway
Senior Project Engineer
Cavan
Principal Process Development Engineer
Galway
Cleaning Validation Specialist
Cork
Clinical Trial Quality Representative
Cork
Design Assurance Engineer
Galway
Senior Electronics Engineer
Dublin
Accreditation Manager
Republic of Ireland
Senior Manufacting Engineer
Republic of Ireland
Senior Equipment Design Engineer
Dublin
Mechanical Technician - 2 Cycle
Carlow
Manufacturing Engineer
Cork
Maintenance Technician
Carlow
(Senior) Manufacturing Engineers - Globa
Limerick
Senior Design Assurance Engineer
Galway
Change Control Lead
Tipperary
Regulatory Affairs Specialist
Cork
Manufacturing Technician
Clare
R&D Manager
Athlone
Quality Engineer
Galway
Responsible Person (RP)
Republic of Ireland
Senior Validation Engineer
Carlow
R&D Engineer
Galway
Clinical Research Associate
Cork
Shift Technician (Injection Moulding)
Kildare
Senior R&D Engineer
Dublin
Account Manager UK and Ireland
Republic of Ireland
Project Engineer
Limerick
Senior R&D Manager - Lifecycle Manag
Galway
R&D Director
Galway
Production Operator
Meath
Project Manager
Kildare
R&D Engineer
Galway
Quality Engineer
Wexford
Cleaning Validation Engineer
Carlow
Senior R&D Engineer
Galway
EHS Systems Specialist
Dublin
Senior Tech Transfer Specialist
Meath
Senior R&D Engineer
Galway
R&D Lifecycle Manager
Connaught
Principal Quality Engineer
Galway
R&D Engineer
Galway
Quality Technician
Dublin
Senior Reg Affairs Specialist - Post Mar
Galway
Regulatory Affairs Associate
Cork
R&D Manager
Connaught
Material Handler
Carlow
Project Manager
Louth
Project Manager - R&D
Galway
Senior R&D Engineer
Galway
Sourcing Specialist
Tipperary
Senior Recruitment Consultant
Republic of Ireland
Maintenance Reliability Engineer
Tipperary
Project Engineer
Clare
Validation Specialist - 50/50 remote
Carlow
Project Manager - R&D
Galway
Principal Process Development Engineer
Dublin
Senior R&D Engineer
Galway
Validation Engineer
Athlone
Associate QA Specialist (Shift)
Carlow
Senior Quality Engineer
Dublin
Senior Regulatroy Affairs Specialsit
Galway
R&D Engineer
Galway
Notified Body Product Assessor -Active D
Canada
Business Systems Director
Louth
R&D Engineer
Galway
Design Quality Assurance Engineer
Galway
Quality Systems Specialist
Tipperary
Quality Manager
Galway
Pharmacovigilance Manager (Remote)
Republic of Ireland
MS&T Associate Director
Dublin
Program Manager
Galway
Senior Quality Engineer
Galway
QC Bioanalytical Analyst
Dublin North
Lead Chemistry Analyst
Cork
Senior R&D Manager/Director
Dublin
Director of Quality Engineering
Limerick
R&D Manager
Galway
Senior Quality Engineer
Leitrim
Quality Engineer
Galway
R&D Engineer
Clare
Quality Specialist
Tipperary
Senior R&D Engineer
Galway
Manufacturing Engineer
Galway
Process Chemist
Limerick
Technical Specialist - Manufacturing Pro
Cork
Senior Regulatory Affairs Specialist
Westmeath
Senior Design Engineer
Dublin
Quality Operations Manager
Dublin
Senior Procurement Associate
Limerick
Senior Project Manager - Process Develop
Dublin
Graduate Manufacturing Technician
Kilkenny
CTO
Galway
R&D Engineer
Galway
Regional Program Coordinator - Global Le
Dublin
QC Laboratory Technician (shift)
Carlow
Quality Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
R&D Manager
Athlone
Senior Design Assurance Engineer
Galway
QA Manager
Canada
R&D Manager
Dublin
R&D Technician II
Galway
Senior Quality Engineer-Remote
Republic of Ireland
Principal/Senior R&D Engineer Cathet
Galway
Biomedical Engineer
Dublin
Quality Specialist
Dublin
Maintenance Technician
Carlow
Software Design Assurance Engineer
Dublin
Embedded Software Engineer
Dublin
R&D Engineer
Galway
Senior Electrical Engineer
Galway
Technical Transfer Specialist - Remote
Republic of Ireland
Senior QC Microbiology
Dublin
Principal Heart Valves Engineer
Galway
R&D Engineer
Galway
Project Scheduler
Louth
Validation & Verification Engineer
Dublin
Product Development Technician II
Galway
Qualified Person (Hybrid)
Tipperary
Head of R&D
Galway
Quality Assurance Specialist (Hybrid)
Dublin
Senior Manufacturing Engineer
Galway
Supply Associate QC - Metrics & Anal
Dublin
Senior Quality Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Qualified Person (Hybrid)
Meath
Senior R&D Engineer
Dublin
Quality Technician
Dublin
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Quality and Regulatroy Manager


Reference:JCAO2709 Location: Galway
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Manager, Quality Manager, Regulatory Affairs Director


QUALITY & REGULATORY MANAGER

Our client an indigenous Irish medical device company who has recently undergone significant investment are currently seeking a Quality and Regulatory Manager to join their team. Reporting to executive leadership the Quality and Regulatory Manager will have a proven ability to lead the quality assurance agenda across the company, possess knowledge of regulatory processes for EU and FDA product clearance, demonstrate excellent people and team management skills and experience of quality management in the context of R&D and design control. This is an exciting opportunity to join a company with huge growth plans


Role/Responsibilities

  • To lead the company wide quality assurance agenda, ensuring that we meet customer requirements for products and services as well as regulatory compliance in target markets
  • Ensure the effective functioning of continuous quality improvement based on performance measurement
  • Ensure there is adequate control of design activity to ensure product quality
  • Lead and manage all areas of Risk management as to relates to design control in accordance with ISO14971
  • Responsible for the ongoing maintenance, audit and continuous improvement of the Quality Management System, to ensure compliance to relevant standards for Europe, UK, North America and Asia Pacific.
  • Responsible for regulatory clearance and regulatory maintenance for the Company’s products in target markets
  • Responsible for the implementation of the Home healthcare and electrical safety standards
  • Management of the QA team
  • Proactive management of the processes to ensure product and service quality
  • Act as Management Representative for the Quality Management System
  • Manage the maintenance of the Quality System to ISO13485, and FDA requirements
  • Responsible for FDA facility inspections, notified body audits and other audits and inspections as required.
  • Establish infrastructure to assure quality and work with relevant teams to ensure performance improvement.
  • Ensure the effective functioning of design controls to ensure product quality.
  • Represent the quality department in all NPI/NPD activities to ensure that all new products are compliant to appropriate international quality and regulatory requirements.
  • Complaints handling for medical reporting and filing to the appropriate competent authorities.
  • Regularly review and manage change control process to ensure it remains effective and efficient.
  • Ensure products are cleared to the appropriate markets as per Regulatory plan
  • Manage Regulatory Affairs support to internal and external customers.
  • Ensure company is kept informed of and give direction on changing regulatory and compliance requirements e.g. REACH, ROHS2, etc.
  • Manage the Quality team to ensure the proactive delivery of departmental objectives and empower the team to actively support and assist other departments in complying with quality requirements.
  • Data collection and analysis for monthly meetings and management review


Skills/Experience

  • University Degree or a Post Graduate qualification, preferably in Quality Assurance
  • 8+ years of experience inMedical Devices or other similar regulated industry
  • Significant regulatory affairs experience including experience of international regulatory processes
  • Knowledge of product certification testing requirements for Medical Devices
  • In depth knowledge of maintaining a certified Quality Management System
  • Knowledge and application of Quality tools and Methodologies including lean six sigma, TQM etc.
  • Previous experience of the impact of regulatory control on commercial products
  • Trained QMS Internal Auditor
  • Awareness of quality assurance processes
  • High level of attention to detail
  • Proven leadership skills
  • Excellent verbal and written communication skills
  • Results orientated and a self-starter with the ability to work on own initiative
  • Knowledge of and commitment to continuous improvement and problem solving
  • Promote best practice and knowledge of the QSR and ISO standards
  • Advanced Microsoft Office and reporting tool skills
  • Strong project management skills



For further information please contact James Cassidy [email protected] or call in confidence 086 0204322