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
R&D Manager
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Injection Molding Engineer
North Leinster
CTO
Dublin
Project Engineer - Senior
Cavan
Electronic Engineer
Dublin
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
Quality Engineer
Galway
Director of R&D
Limerick
R&D Engineer
Clare
R&D Lifecycle Manager
Connaught
Documentation Specialist
Louth
Quality Control Analyst (shift)
Carlow
Senior R&D Engineer
Galway
Senior Project Engineer
Cavan
Staff R&D Engineer
Limerick
Project Manager - R&D
Galway
Senior R&D Engineer
Galway
Principal R&D Engineer
Dublin
Electronic Engineer
Dublin
Senior Design Engineer
Dublin
Electronic Engineer
Dublin
Senior Regulatory Affairs Specialist
Westmeath
Injection Molding Engineer
North Leinster
Senior R&D Engineer
Dublin
Product Development Engineer
Dublin
Senior Process Engineer
Longford
Senior Electronic Engineer
Dublin
Senior Quality Engineer
Dublin
Senior R&D Engineer
Galway
Senior R&D Engineer
Clare
Product Development Manager
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Senior R&D Engineer
Galway
Quality Assurance Specialist (hybrid)
Dublin
Product Development Engineer II
Athlone
Process Engineer
Leitrim
Senior Regulatory Specialist
Cork
Senior QC Associate
Dublin
Senior Design Assurance Engineer
Galway
Quality Engineer
Athlone
Process Chemist
Limerick
Manufacturing Technician
Clare
Product Development Technician II
Galway
Senior Principal R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
R&D Manager
Athlone
Advanced Technologies R&D Manager
Clare
Manufacturing Technician
Clare
Injection Moulding Engineer
Athlone
Senior Quality Control Associate
Dublin South
Clinical Seating Specialist - Primary Ca
Dublin
Engineering Support Specialist
Louth
Product Specialist (Endoscopy)
Dublin
Senior Mechanical Engineer
Dublin
Project Manager Design Assurance
Galway
Validation & Verification Engineer
Dublin
Senior Quality Engineer
Leitrim
Senior Quality Engineer
Dublin
Quality Manager
Dublin
Senior Electronic Engineer - Regulated M
Galway
Design Assurance Engineer
Galway
Injection Molding Engineer
North Leinster
Senior Associate Quality Control (Shift)
Dublin
CTO
Galway
Senior R&D Engineer
Dublin
Senior Design Assurance Engineer
Athlone
Senior Equipment Design Engineer
Dublin
Quality Assurance Specialist (shift)
Carlow
R&D Engineer
Galway
Manufacturing Technician
Clare
Inside Sales Representative (IVD Divisio
Kildare
Quality Manager - NPI
Dublin
Senior Quality Engineer
Galway
Quality Manager
Dublin
Calibration Technician
Republic of Ireland
Biomedical Engineer
Dublin
Quality Engineer
Galway
R&D Manager
Connaught
Senior Maintenance Technician
Kilkenny
Product Development Engineer
Dublin
R&D Manager
Galway
Product Development Engineer
Dublin
Quality Assurance Senior Specialist
Louth
R&D Engineer
Galway
Senior Product Development Engineer
Galway
Electronic Engineer
Dublin
Project Engineer
Republic of Ireland
Principal R&D Engineer
Galway
Quality Assurance Specialist (shift)
Carlow
R&D Engineer
Galway
Senior Design Assurance Engineer
Galway
Pharmacovigilance Manager (Remote)
Republic of Ireland
Quality Manager - Medical Devices
Limerick City
Senior Equipment Design Engineer
Dublin
Shift Technician (Injection Moulding)
Kildare
Senior R&D Engineer
Galway
Product Development Manager
Galway
Senior Research and Development Engineer
Galway
Supply Chain Project Manager (hybrid)
Dublin
Senior R&D Engineer
Clare
R&D Engineer
Galway
R&D Manager
Galway
Senior Quality Systems Engineer
Galway
Senior Regulatory Affairs Specialist
Clare
Engineering Shift Technician
Dublin
Senior Equipment Engineer
Dublin
Senior Quality Engineer
Leitrim
Embedded Software Engineer
Dublin
Principal Engineer
Dublin
R&D Manager
Galway
Project Engineer
Cork
Responsible Person (RP)
Republic of Ireland
QA Engineer
Leitrim
Director of R&D
Clare
Quality Specialist
Tipperary
Advanced Technologies R&D Manager
Clare
Senior Equipment Design Engineer
Dublin
Purchasing & Planning Manager
Wexford
Process Engineer
Galway
R&D Engineer
Dublin
Senior Engineering Manager
Limerick
Sr Principal R&D Engineer
Galway
Product Development Technician II
Galway
R&D Director
Galway
Senior R&D Engineer II
Galway
R&D Engineer
Galway
Senior Regulatory Affairs Manager
Galway
Project Manager Design Assurance
Galway
Senior Quality Engineer
Leitrim
Reg Affairs Specialist
Connaught
R&D Manager
Connaught
Senior R&D Manager - Lifecycle Manag
Galway
Project Manager
Kildare
Principal Device Engineer
Dublin
Electronic Engineer
Dublin
Project Manager
Kildare
Regulatory Affairs Maanger
Galway
Principal Software Engineer
Athlone
Principal Process Equipment Engineer
Dublin South
Design Assurance Program Manager
Galway
Quality Assurance Team Lead
Cork
R&D Engineer
Galway
Principal Design and Development Enginee
Galway
Senior Electronic Engineer
Dublin
R&D Manager
Galway
Electrical Condition Monitoring Technici
Limerick
Senior Regulatroy Affairs Specialsit
Galway
R&D Engineer
Galway
Software Design Assurance Engineer
Dublin
R&D Engineer
Galway
Principal R&D Engineer
Galway
Senior R&D Engineer
Galway
Electronic Engineer
Dublin
Operations Engineer
Galway
Electronic Engineer
Dublin
Senior Manufacting Engineer
Republic of Ireland
Senior R&D Engineer-New Product Deve
Westmeath
Business Excellence Lead (Manufacturing)
Wexford
R&D Manager
Athlone
Electrical Technician
Limerick
Principal Instrumentation & Calibrat
Limerick
Senior Microbiologist
Dublin
R&D Engineer
Galway
Technical Marketing Manager
Wexford
Health & Safety Specialist
Louth
Validation Engineer
Republic of Ireland
Staff Systems Engineer
Limerick
Senior Principal R&D Engineer
Galway
R&D Manager
Connaught
Senior Quality Engineer
Galway
Business Development Manager (Pharma &am
Republic of Ireland
Cleaning Validation Engineer
Republic of Ireland
Project Manager - R&D
Galway
Quality Manager
Galway
QC Microbiology Specialist
Carlow
Senior R&D Engineer
Galway
Principal R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
Quality Assurance Specialist/Manager
Dublin
Senior Electronics Engineer
Limerick
R&D Manager
Connaught
Production Manager
Dublin
Documentation Specialist
Louth
R&D Engineer
Galway
Design Assurance Engineer
Clare
Principal R&D Engineer
Galway City
Product Development Engineer
Galway
Design Assurance Engineer
Galway
R&D Director
Galway
Electronic Engineer
Dublin
Senior Regulatory Affairs
Galway
R&D Engineer
Dublin
Injection Moulding Engineer
Athlone
QA Manager
Canada
Process Engineer Specialist
Carlow
Quality Engineer
Galway
R&D Manager
Dublin
Application Software Engineer
Galway
Quality Technician
Dublin
Regulatory Specialist
Galway
Senior Design Engineer
Dublin
Senior R&D Engineer
Dublin
R&D Director
Galway
Product Development Engineer
Galway
Quality Systems Manager
Dublin
Product Development Engineer II
Athlone
Senior R&D Engineer
Galway
R&D Engineer
Galway
Process Engineer
Carlow
Regulatory Affairs Specialist
Cork
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]