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
Manufacturing Technician
Clare
Senior Associate Quality Control NPI
Dublin
Specialist Operations Engineer
Tipperary
Senior E&I Maintenance Technician
Carlow
R&D Engineer
Dublin
Engineering Shift Technician
Dublin
Quality Engineer
Galway
Remote Process Engineer - Fill Finish
Republic of Ireland
Senior Electrical Engineer
Galway
Batch Record Reviewer
Cork
Senior Manufacturing Manager (hybrid)
Dublin
Quality Assurance Engineer
Longford
Associate Director Clinical Development
Cork
R&D Manager
Connaught
NPI Process Engineer
Carlow
QA Manager
Canada
R&D Director
Galway
Aseptic Process Lead
Carlow
Senior Recruitment Consultant
Cork
Electrical and Instrumentation Turnover
Carlow
R&D Engineer
Galway
Senior Quality Control Associate
Dublin South
E&I Turnover Engineer
Carlow
Senior Operations Engineer
Galway
Project Manager
Limerick
Quality Control Specialist (hybrid)
Carlow
R&D Manager
Connaught
E&I Turnover Engineer
Carlow
Senior Regulatory Affairs Specialist
Athlone
Clinical Project Statistician
Cork
R&D Director
Galway
Production Operator
Carlow
Senior Electronic Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Medical Device Director
Republic of Ireland
Process Simulation Technical Engineer
Carlow
Senior Equipment Design Engineer
Dublin
Validation Engineer
Athlone
Senior Research and Development Engineer
Galway
Lead Maintenance Reliability Engineer
Westmeath
Regional Program Coordinator - Global Le
Dublin
R&D Manager
Galway
QA Lead DS/DP Manufacturing
Louth
Upstream Manufacturing Process Specialis
Cork
Senior R&D Manager - Lifecycle Manag
Galway
QC Bioassay Analyst (shift)
Carlow
Project Engineer
Limerick
Senior Human Factors Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Process Engineer - Technical Specialist
Cork
Mechanical Design Engineer
Germany
Senior Project Equipment Engineer
Dublin
Senior Maintenance Technician
Roscommon
QC Laboratory Technician Shift (Incoming
Carlow
Qualified Person
Limerick
Senior Electronic Engineer
Dublin
R&D Engineer
Galway
Senior Electronics Engineer
Dublin
Injection Moulding Engineer
Athlone
Technical Transfer Specialist - Remote
Republic of Ireland
Reliability Engineering Specialist
Louth
Software Design Assurance Engineer
Dublin
R&D Engineer
Galway
Project Manager - Suite Lead
Tipperary
Principal R&D Engineer
Galway
Documentation Specialist
Cork
R&D Manager
Galway
Senior Quality Engineer
Leitrim
Senior Recruitment Consultant
Republic of Ireland
Project Manager - R&D
Galway
Senior Equipment Engineer
Dublin
Senior Regulatroy Affairs Specialsit
Galway
Strategic Automation Lead
Waterford
Associate Global Trade Ops
Dublin
Quality Specialist
Tipperary
Senior Recruitment Consultant
Dublin
Process Support Specialist
Carlow
Senior R&D Engineer
Galway
Maintenance Engineer
Cork
Manufacturing Technician
Clare
Technical Specialist - Manufacturing Pro
Cork
Recruitment Consultant
Republic of Ireland
Quality Systems Manager
Dublin
EHS Systems Specialist
Carlow
Project Manager - R&D
Galway
Process Engineer
Galway
CMC Regulatory Principal Scientist
Cork
Lead Maintenance Reliability Engineer
Westmeath
Senior Equipment Design Engineer
Dublin
C&Q Lead
Tipperary
Technical Sales Manager (Chemistry)
Westmeath
Suite Team Delivery Lead
Tipperary
Senior Mechanical Engineer
Dublin
Cell Culture Analyst
Carlow
Maintenance CMMS Engineer
Tipperary
CEP Revisions Team leader B5
France
Maintenance Engineer
Cork
Associate Director Clinical Regulatory S
Cork
Operational Excellence Specialist
Meath
Project Manager - Capital Projects
Meath
Chemical Engineer
Tipperary
Senior Project Manager - Process Develop
Cork
Senior Regulatory Affairs Specialist
Dublin
Principal/Senior R&D Engineer Cathet
Galway
R&D Director
Galway
Technical Life Cycle & Engineering M
Galway
Senior Electronic Engineer
Dublin
Cleaning Validation Specialist
Cork
Principal Scientist Global Regulatory Af
Cork
Senior Operations Engineer
Galway
QA Engineer
Leitrim
Engineering Projects Lead
Carlow
Senoior Specialist - MS&T
Dublin
Maintenance Reliability Engineer
Cork
Medical Science Liaison (MSL)
Dublin
CQV Engineer (CIP Start Up)
Denmark
Senior Project Engineer - Utilities
Dublin
Manufacturing Technician
Clare
Biostatistician
Dublin City Centre
QC Laboratory Technician (shift)
Carlow
Senior QC 24/7 Shift
Dublin
Quality Technician
Dublin
Project Engineer
Clare
R&D Manager
Galway
Project Engineer
Tipperary
R&D Project Manager
Galway
Process Engineer (NPI)
Carlow
Project Process Engineer
Carlow
R&D Engineer
Galway
Quality Systems Specialist
Galway
QC Separation Analyst
Cork
Microbiology Manager
Dublin
Quality Specialist - Remediation
Louth
Program Manager
Cork
Project Enginer
Dublin South
CQV Lead
Tipperary
Associate Quality Specialist
Cork
Pharmacovigilance Manager (Remote)
Republic of Ireland
Product Development Engineer
Galway
Manufacturing Technician
Clare
Compliance Specialist
Carlow
Associate Quality Specialist
Tipperary
Sales Executive (Nutritional Supplements
Cork
Product Lead
Dublin
Senior Design Engineer
Dublin
Quality Engineer
Athlone
Operations Specialist
Louth
Senior Polymer Development Engineer
Galway
Commissioning and Qualification Engineer
Cork
Senior Quality Engineer
Leitrim
Quality Control Analyst
Greece
CSV Engineer - IT Labs
Limerick
Procurement Senior Specialist
Meath
CQV Engineer (Clean Utilities)
Dublin South
Senior Project Engineer
Cork
QA Operations Specialist
Greece
Account Manager UK and Ireland
Republic of Ireland
Cleaning Validation Specialist
Cork
Project Engineer
Republic of Ireland
Senior R&D Engineer
Galway
Electrical Engineer
Cork
Manager R&D
Connaught
Senior Design Engineer
Dublin
R&D Manager
Connaught
R&D Manager
Galway
Product Development Engineer II
Athlone
Manufacturing Engineer
Limerick
Head of R&D
Galway
Senior Validation Engineer
Limerick
Process Engineer - Water Formulations
Limerick
Senior Quality Engineer
Leitrim
Senior R&D Manager - Lifecycle Manag
Galway
Business Systems Director
Louth
Staff R&D Engineer- Customer Focus
Dublin
Senior Validation Engineer
Dublin
Process Engineer
Limerick
Bioprocess Material Associate - Shift
Dublin
Clean Utilities Engineer
Cork
Senior Design Quality Engineer
Dublin
Technical Specialist - Process Support
Cork
Electronic Design Engineer
Galway
Quality Validation Engineer
Limerick
Technical Transfer Lead
Dublin
Microbiologist
Louth
R&D Engineer
Clare
Mechanical Technician - 2 Cycle
Carlow
Maintenance Engineer
Carlow
Senior Quality Engineer
Dublin
Cleaning Validation Specialist
Cork
Shift Technician (Injection Moulding)
Kildare
Senior Electronic Design Engineer
Dublin
Cleaning Validation Engineer
Denmark
R&D Engineer
Dublin
Senior Recruitment Consultant
Dublin
Procurement Senior Specialist
Meath
Senior R&D Engineer
Dublin
R&D Manager
Connaught
Regional Procurement Senior Specialist (
Dublin
Electrical Engineer
Limerick
Senior Manufacting Engineer
Republic of Ireland
Sales/Customer Service Administrator
Clonmel
Responsible Person (RP)
Republic of Ireland
EHS Systems Specialist
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
QA Manager
Canada
Qualified Person
Limerick
MES Engineer
Cork
Senior Regulatory Affairs Specialist
Clare
R&D Engineer
Galway
Biostatistician
Dublin City Centre
Senior Regulatory Affairs Specialist
Athlone
Senior Quality Engineer
Leitrim
R&D Engineer
Clare
Notified Body Product Assessor -Active D
Canada
Principal Process Equipment Engineer
Dublin South
Cleaning Validation Engineer
Cork
Batch Record Reviewer
Cork
Quality Control Technician
Carlow
Cleaning Validation Specialist
Cork
Compliance Specialist
Carlow
Senior R&D Engineer
Clare
Senior Operations Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Technical Specialist - Manufacturing Pro
Cork
Aseptic Process Owner Lead
Dublin
Senior Validation Engineer
Limerick
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

Senior Regulatory Affairs


Reference:JCAO1010 Location: Galway
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs, Senior Regulatory Affairs Officer

Our client a growing medical device organisation currently seeks a Senior Regulatory Affairs Specialist to join their team. The Senior Regulatory Affairs Specialist will be responsible for all regulatory activities including product certification and compliance, and for supporting the ongoing maintenance, audit and continuous improvement of specific elements of the Quality Management System


Role/Responsibilities

  • Manage the regulatory and vigilance process.
  • Prepare regulatory submissions for required markets coordinating input from other stakeholders, tracking and supporting product clearances and certification to completion.
  • Maintain technical files for all cleared products.
  • Support the Senior Quality & Regulatory Manager in managing any required product certification testing.
  • Support the Senior Quality & Regulatory Manager in managing the Risk Management process for all existing and new products.
  • Complaints handling for medical reporting and filing to the appropriate competent authorities.
  • Keep up to date with changing regulatory and compliance requirements e.g., REACH ROHS2 etc.
  • Maintain environmental registrations for all markets.
  • Support labelling and packaging updates and creations from a regulatory and clinical claims perspective.
  • Complete internal audits as required and lead CE technical file audits for the company.
  • Support the Quality team in maintaining the QMS
  • Expert Knowledge of regulatory processes for EU, UK and FDA product clearance.
  • Working experience of regulatory processes for ROW markets.
  • Working experience of a certified Quality Management System.


Skills/Experience:
  • You will have a third level degree and a significant amount of experience in medical devices.
  • A post-graduate qualification in Quality Assurance along with experience of active medical devices would be an advantage.
  • Significant regulatory affairs experience including experience of international regulatory processes.
  • In depth knowledge of product certification testing requirements for active 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.
  • Experience of EN/MDD/MDR, ISO13485 and FDA requirements.
  • Trained QMS Internal Auditor.
  • Strong attention to detail.
  • 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/MDD 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 [email protected]