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 Engineer
Dublin
Senior Quality Engineer
Galway
Senior R&D Engineer
Galway
R&D Engineer
Galway
R&D Manager
Galway
R&D Manager
Connaught
Validation Engineer
Republic of Ireland
Senior Quality Control Associate
Dublin South
Business Excellence Lead (Manufacturing)
Wexford
Senior Quality Engineer
Dublin
Senior R&D Engineer
Clare
Senior Quality Engineer
Dublin
Calibration Technician
Republic of Ireland
Senior Quality Systems Engineer
Galway
Senior QC Associate
Dublin
Principal Quality Engineer
Galway
Principal R&D Engineer
Galway
Senior R&D Engineer
Galway
Project Manager
Kildare
Quality Engineer
Athlone
Senior R&D Engineer
Galway
Project Engineer
Republic of Ireland
Process Chemist
Limerick
Senior Manufacting Engineer
Republic of Ireland
Product Development Engineer
Dublin
Product Development Technician II
Galway
Continuous Improvement Coach
Limerick
Injection Moulding Engineer
Leitrim
Senior Maintenance Technician
Kilkenny
Engineering Manager
Galway
Quality Engineer
Galway
Injection Moulding Engineer
Athlone
Quality Engineer - Supplier
Galway
Senior R&D Engineer
Galway
Quality Engineer
Wexford
R&D Technician II
Galway
Quality Engineer
Galway
QA Engineer
Leitrim
Business Development Manager (Pharma &am
Republic of Ireland
R&D Manager
Galway
Quality Engineer
Galway
Senior Design Assurance Engineer
Galway
Regulatory Specialist
Galway
R&D Engineer
Galway
Senior R&D Engineer
Galway
Business Development Manager (Pharma &am
Republic of Ireland
Project Manager - R&D
Galway
Mechanical Engineer
Dublin
Senior QC Technical Services - Equipment
Dublin
Process Engineer
Leitrim
Project Manager - New Product Introducti
Dublin
Senior R&D Engineer
Dublin
Shift Technician (Injection Moulding)
Kildare
Validation Engineer
Athlone
R&D Engineer
Galway
Senior Quality Engineer
Leitrim
R&D Manager
Dublin
Senior R&D Engineer
Dublin
Senior Research and Development Engineer
Galway
R&D Manager
Connaught
Senior R&D Engineer
Dublin
Senior Reg Affairs Specialist - Post Mar
Galway
Senior Design Assurance Engineer
Athlone
R&D Engineer
Galway
Senior Design Assurance Engineer
Galway
QC Instrumentation Specialist
Dublin
Senior QC Associate (Bioassay)
Dublin
Senior QA Associate (24/7 Shift)
Dublin
Quality Assurance Specialist/Manager
Dublin
R&D Engineer
Galway
Warehouse Operator
Meath
Senior Regulatory Affairs Manager
Galway
Senior R&D Engineer
Galway
Sales/Customer Service Administrator
Clonmel
Learning Systems Lead
Limerick
Senior Quality Assurance Specialist
Cork
Quality Assurance Specialist (hybrid)
Dublin
Senior Regulatroy Affairs Specialsit
Galway
Senior R&D Engineer
Galway
R&D Engineer
Galway
Quality Manager - NPI
Dublin
Senior Product Development Engineer
Galway
Senior R&D Manager
Athlone
Strategic Automation Lead
Waterford
Quality Systems Manager
Dublin
R&D Director
Galway
Application Software Engineer
Galway
Embedded Software Engineer
Dublin
Manufacturing Technician
Clare
Project Manager Design Assurance
Galway
Cleaning Validation Engineer
Republic of Ireland
Purchasing & Planning Manager
Wexford
Principal Engineer
Dublin
R&D Engineer
Clare
Senior Process Engineer
Dublin
CTO
Galway
Injection Molding Engineer
North Leinster
Supplier Quality Engineer
Galway
Quality Manager
Galway
Senior Operations Engineer
Galway
Senior Quality Engineer
Dublin
Project Manager - R&D
Galway
Senior Equipment Design Engineer
Dublin
Senior Regulatory Specialist
Cork
Senior Regulatory Affairs Specialist
Athlone
Analytical Chemist
Tipperary
Advanced Technologies R&D Manager
Clare
Senior R&D Manager - Lifecycle Manag
Galway
Documentation Specialist
Louth
R&D Engineer
Dublin
Senior Process Development Engineer
Galway
Quality Manager
Dublin
Principal R&D Engineer
Galway
Injection Moulding Engineer
Athlone
Warehouse Operator
Meath
Health & Safety Specialist
Louth
Project Manager - R&D
Galway
Staff R&D Engineer
Limerick
Senior Validation Engineer - HVAC
Dublin
Quality Engineer
Galway
Responsible Person (RP)
Republic of Ireland
Electronic Engineering
Dublin
R&D Engineer
Galway
Senior R&D Manager
Athlone
Design Assurance Program Manager
Galway
Senior R&D Engineer
Galway
Senior Electronic Engineer
Dublin
QA Manager
Canada
Senior Project Engineer
Cavan
CTO
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior R&D Manager - Lifecycle Manag
Galway
Senior Research & Development Engine
Limerick
R&D Manager
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior Quality Assurance Specialist (hyb
Dublin
Senior Manufacturing Engineer
Galway
Principal R&D Engineer
Galway City
Quality Engineer
Athlone
Product Development Technician II
Galway
R&D Engineer
Galway
Senior R&D Engineer
Galway
Product Development Engineer
Dublin
Inside Sales Representative (IVD Divisio
Kildare
Technical Life Cycle & Engineering M
Galway
Graduate QC Associate - Data Analytics
Dublin
Project Engineer - Senior
Cavan
R&D Manager
Athlone
Senior QC Associate
Dublin
Senior Regulatory Affairs Manager
Galway
Product Development Engineer
Dublin
R&D Manager
Athlone
Senior R&D Engineer
Galway
R&D Manager
Galway
Quality Manager
Dublin
Quality Assurance Specialist (hybrid)
Dublin
Product Development Engineer
Galway
Purchasing & Planning Manager
Wexford
Product Development Engineer II
Athlone
Director of R&D
Clare
Validation & Verification Engineer
Dublin
Senior Quality Engineer
Dublin
Injection Molding Engineer
North Leinster
Technical Marketing Manager
Wexford
Senior Principal Design and Development
Galway
Senior Project Engineer
Cavan
R&D Director
Galway
Product Development Engineer II
Athlone
Senior Regulatory Affairs Specialist
Westmeath
Senior Electronic Engineer
Dublin
Process Development Engineer
Galway
R&D Engineer
Galway
R&D Manager
Connaught
Injection Molding Engineer
North Leinster
Engineering Shift Technician
Dublin
Commercial Attribute Science Scientist
Dublin
Product Development Engineer
Galway
Senior R&D Engineer
Galway
Sales Manager (Healthcare)
Dublin
Engineering Manager
Galway
Electronic Engineer
Dublin
R&D Director
Galway
Senior Equipment Design Engineer
Dublin
Staff Systems Engineer
Limerick
Principal R&D Engineer
Dublin
Senior Design Assurance Engineer
Galway
Design Quality Engineer
Galway
R&D Manager
Galway
R&D Manager
Connaught
Senior R&D Engineer-New Product Deve
Westmeath
Engineering Manager
Galway
Senior Manufacturing Engineer
Galway City
R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
Principal Design and Development Enginee
Galway
Commercial Attribute Science Snr Associa
Dublin
Senior Mechanical Engineer
Dublin
Senior R&D Engineer
Dublin
Director of R&D
Limerick
R&D Engineer
Galway
Senior Quality Engineer
Dublin
Quality Specialist
Tipperary
Senior Regulatory Affairs
Galway
Technical Life Cycle & Engineering M
Galway
Senior Equipment Design Engineer
Dublin
Quality Manager
Galway
Project Engineer
Clare
Senior Design Assurance Engineer
Galway
Manufacturing Technician
Clare
Senior Regulatory Specialist
Cork
Principal Software Engineer
Athlone
Principal Engineer
Dublin
Quality Assurance Specialist (Logistics)
Dublin
Project Engineer
Cork
Senior R&D Engineer
Galway
R&D Project Manager
Galway
Quality Assurance Team Lead
Cork
Quality Engineer
Galway
Injection Moulding Engineer
Athlone
Quality Assurance Team Lead
Cork
Project Manager - R&D
Galway
Quality Specialist
Clare
Senior Electronics Engineer
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Project Manager
Kildare
Project Engineer
Roscommon
Director of Regulatory Affairs
Galway
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