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
Quality Manager
Galway
Business Development Manager
Republic of Ireland
Quality Assurance Specialist/Manager
Dublin
Embedded Software Engineer
Dublin
Senior R&D Engineer
Galway
R&D Engineer
Galway
Quality Engineer
Athlone
Design Assurance Engineer
Galway
Quality Systems Manager
Dublin
Senior Clinical Data Analyst
Dublin
Director of R&D
Limerick
Senior Electronics Engineer
Dublin
Principal R&D Engineer
Galway
R&D Director
Galway
CAPEX API Project Manager
Tipperary
R&D Senior Program Manager
Galway
Senior R&D Engineer
Galway
Regulatory Affairs Specialist
Cork
Supplier Quality Engineer
Galway
R&D Director
Galway
Product Development Technician II
Galway
Commercial Solutions Manager (Medical De
Dublin
Quality Technician
Dublin
QA Operations Specialist
Dublin
Principal Reliability Engineer
Galway
Senior Process Development Engineer
Galway
LIMS Specialist
Tipperary
R&D Manager
Galway
Project Manager
Galway
Quality Engineer
Galway
Supply Chain Specialist - New Material I
Meath
Senior Regulatory Affairs Specialist
Athlone
R&D Engineer
Dublin
Marketing Manager
Galway
Senior Equipment Engineer
Dublin
Senior Associate Quality Control
Dublin
R&D Manager
Galway
Senior Electronic Engineer
Dublin
Senior QC Specialist - Equipment & I
Dublin
Quality Specialist
Tipperary
Senior Specialist MS&T
Dublin
Senior R&D Engineer
Galway
Calibration Technician
Republic of Ireland
Manufacturing Technician
Clare
Principal R&D Engineer
Dublin
Operations Manager
Galway
Sales/Customer Service Administrator
Clonmel
Product Specialist - Imaging/ Radiograph
Dublin
Senior R&D Engineer
Galway
Purchasing & Planning Manager
Wexford
Director of Regulatory Affairs
Galway
R&D Manager
Galway
QC Bioassay Specialist
Cork
Senior Quality Assurance Associate
Dublin
Senior Scientist IVD Assay Development
Galway
Senior Technology Transfer Specialist
Dublin
Biomedical Engineer
Dublin
Quality Manager
Galway
Quality Manager
Galway
Reg Affairs Specialist
Connaught
Quality Assurance Team Lead
Cork
R&D Engineer
Galway
Tech Transfer Lead
Dublin
Operations Engineer
Galway
Quality Engineer
Athlone
Senior Equipment Design Engineer
Dublin
R&D Engineer
Galway
Manufacturing Technician
Galway
Senior QA Associate (Investigation Lead)
Dublin
EHS Specialist II
Limerick
Laboratory Analyst in Forensic Science I
Kildare
Regulatory Affairs Manager - Senior
Galway
Regulatory Affairs Maanger
Galway
Product Development Engineer II
Athlone
Engineering Business Manager
Dublin
Senior R&D Engineer
Galway
Senior QA Associate (shift)
Dublin
Quality Assurance Specialist (shift)
Carlow
R&D Manager
Connaught
Senior Operations Engineer
Galway
Quality Assurance Associate
Cork
Quality Manager - Medical Devices
Limerick City
Quality Assurance Specialist (hybrid)
Dublin
Senior Maintenance Technician
Roscommon
Senior Engineering Manager
Limerick
Senior Electrical Engineer
Galway
Process Engineer
Galway
Construction Manager - Pharma/Biotech
Dublin
QA Engineer
Leitrim
Senior Quality Engineer
Dublin
Senior R&D Engineer
Dublin
Senior Manufacturing Engineer
Galway
Warehouse Operator
Dublin
R&D Engineer
Galway
Senior Director of Manufacturing and Sup
Galway
R&D Director
Galway
(Senior) Manufacturing Engineers - Globa
Limerick
Director of R&D
Clare
Senior Reg Affairs Specialist - Post Mar
Galway
R&D Engineer
Galway
R&D Manager
Galway
R&D Technician
Galway
Validation Engineer
Republic of Ireland
Design Assurance Engineer
Galway
Responsible Person (RP)
Republic of Ireland
Product Development Technician II
Galway
Senior Equipment Design Engineer
Dublin
Principal R&D Engineer
Dublin
Senior R&D Manager
Athlone
Senior Process Engineer
Longford
Production Manager
Dublin
Senior Project Engineer
Cavan
Principal R&D Engineer
Galway
Senior Quality Assurance Specialist (hyb
Dublin
Quality Engineer - Supplier
Galway
Injection Moulding Engineer
Athlone
Quality Engineer
Galway
Advanced Technologies R&D Manager
Clare
Senior Principal Design and Development
Galway
Senior Design Assurance Engineer
Galway
Analytical Chemist
Tipperary
Advanced Technologies Manager
Galway
Principal Device Engineer
Dublin
Senior R&D Engineer
Galway
R&D Engineer
Galway
Senior Manufacting Engineer
Republic of Ireland
QA Specialist (Investigation Lead)
Dublin
Process Chemist
Limerick
R&D Manager
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior Equipment Design Engineer
Dublin
R&D Engineer
Clare
R&D Lifecycle Manager
Connaught
Senior Quality Control Associate
Dublin South
Validation Engineer
Carlow
Senior Design Engineer
Dublin
Mechanical Technician
Carlow
Graduate Occupational Hygiene Consultant
Kildare
Quality Engineer
Galway
Project Manager
Kildare
Senior Regulatory Affairs
Galway
Senior R&D Manager
Athlone
Product Specialist (Critical Care &
Dublin
Key Account Manager - Retail UK National
South East
Quality Manager
Dublin
Technical Life Cycle & Engineering M
Galway
Project Manager
Kildare
Strategic Automation Lead
Waterford
Principal Design Assurance Engineer
Galway
Senior Quality Engineer
Dublin
Design Quality Engineer
Galway
CTO
Dublin
Director Engineering & Supply Chain
Galway
Project Manager - R&D
Galway
Product Development Engineer
Dublin
Quality Assurance Senior Specialist
Louth
Quality Specialist
Clare
Senior Quality Engineer
Dublin
Senior R&D Engineer
Dublin
Quality Specialist
Clare
R&D Manager
Connaught
Senior Regulatory Affairs Specialist
Athlone
Senior Quality Engineer
Dublin
Principal R&D Engineer
Galway
Quality and Regulatory Affairs Manager
Dublin
Software Design Assurance Engineer
Dublin
Senior QC Microbiology
Dublin
Purchasing & Planning Manager
Wexford
Associate Quality Assurance Specialist
Tipperary
Senior Quality Assurance Specialist
Cork
R&D Program Manager
Dublin
Laboratory Systems Specialist
Meath
Senior Process Engineer - DP or DS
Dublin
Senior Quality Engineer
Leitrim
Lead MSAT Validation Consultant
Republic of Ireland
Senior Engineering Manager
Galway
Product Specialist (Critical Care &
Dublin
R&D Technician II
Galway
Quality Assurance Specialist
Carlow
Product Development Engineer
Galway
Senior Operations Engineer
Galway
R&D Engineer
Dublin
Senior Manufacturing Engineer
Cork
R&D Manager
Dublin
Inside Sales Representative (IVD Divisio
Kildare
Senior R&D Engineer
Clare
QA Manager
Canada
R&D Manager
Athlone
Principal Engineer
Dublin
CTO
Galway
Senior Commissioning & Qualification
Roscommon
Shift Technician (Injection Moulding)
Kildare
R&D Engineer
Galway
Product Development Engineer
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Senior Regulatory Affairs Specialist
Dublin
Senior Regulatory Affairs Specialist
Clare
R&D Engineer
Galway
QA Deviations Specialist
Dublin
Senior Quality Assurance Technical Suppo
Dublin
Senior Quality Engineer
Leitrim
Senior R&D Engineer II
Galway
Quality Assurance Specialist (shift)
Carlow
R&D Manager
Connaught
Senior R&D Manager - Lifecycle Manag
Galway
R&D Technician II
Galway
R&D Manager
Athlone
EHS Specialist II
Limerick
Quality Technician
Dublin
Process Development Engineer
Galway
R&D Manager
Connaught
Validation & Verification Engineer
Dublin
Senior Maintenance Technician
Kilkenny
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 Regulatroy Affairs Specialsit


Reference:JCAO0926 Location: Galway
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs, Senior Regulatory Affairs Officer


Senior Regulatory Specialist

Our client a well funded high potential medical device start up are currently seeking experienced regulatory professional top join their team. The Senior Regulatory Affairs Specialist will work closely with a cross-functional team to obtain the regulatory approvals/clearances needed to support clinical and commercial use of an innovative new therapy.


Role/Responsibilities

  • Support and advise the VP Quality and Regulatory Affairs by executing regulatory activities and developing regulatory strategies to support the needs of the business.
  • Develop regulatory submissions to ensure timely product clearance/approval and lead preparation, review and submission of high-quality responses to questions from regulatory agencies.
  • Collaborate with the development team to ensure that the data is created using best scientific principles and that submission goals are met.
  • Develop and manage product design and technical documentation in compliance with the relevant regulations and standards, ensuring that data is controlled and is appropriately protected from corruption, misuse or damage.
  • Assure compliance to applicable laws and regulations of all applicable Health Authorities related to obtaining product approval and maintaining product marketing rights.
  • Monitor emerging legislation and guidance in appropriate jurisdictions and contribute to ensuring company-level awareness and compliance where appropriate.

Skills/Experience:
  • A Bachelor’s or Master’s degree in a scientific or engineering discipline.
  • At least 7 years’ experience in Quality Assurance or Regulatory Affairs for medical device companies, with a track record of success with IDE, FDA 510(k) and PMA submissions.
  • Strong experience preparing and reviewing regulatory submissions to achieve timely approval.
  • Collaborative team player with solid knowledge of the medical device design and development process.
  • Excellent written, interpersonal communication and presentation skills.
  • High level of organization with the ability to manage multiple projects.
  • Able to apply excellent analytical and computer skills in conducting research, analysing data and writing technical documents -


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