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
Galway
Commissioning, Qualification and Valid
Carlow
Project Engineer
Tipperary
Production Operator
Carlow
Process Engineer - Water Formulations
Limerick
Quality Specialist
Tipperary
Senior Validation Engineer
Limerick
Instrument Specialist
Tipperary
Cleaning Validation Specialist
Cork
R&D Manager
Galway
Regulatory Affairs Associate
Cork
R&D Engineer
Dublin
Quality Specialist
Clare
Senior Cleaning Validation Engineer
Carlow
R&D Manager
Dublin
Project/Process Engineer - Purification
Cork
Process Chemist
Limerick
R&D Engineer
Galway
Quality Specialist
Clare
Principal Heart Valves Engineer
Galway
Medical Writer
Cork
Quality Manager
Dublin
Technical Administrator
Tipperary
Senior Validation Engineer
Dublin
Senior Design Engineer
Dublin
Senior Manager Device Supplier Assurance
Dublin
Buyer
Wexford
Senior Equipment Design Engineer
Dublin
Project Manager - Capital Projects
Meath
R&D Manager
Connaught
Commissioning and Qualification Engineer
Cork
Associate Director Clinical Development
Cork
Senior HVAC Engineer
Dublin
QA Manager
Canada
Project Engineer
Limerick
Senior Quality Engineer
Leitrim
Senior Project Equipment Engineer
Dublin
R&D Director
Galway
Process Engineer
Limerick
QC Separation Analyst
Cork
Injection Moulding Engineer
Athlone
Manufacturing Engineer
Wexford
Manufacturing Project Engineer
Sligo
Biostatistician
Dublin City Centre
R&D Project Manager
Galway
QA Manager
Canada
Senior Project Engineer
Cavan
C&Q Lead
Tipperary
Validation Specialist
Cork
R&D Engineer
Galway
Quality Control NPI Senior Associate
Dublin South
Quality Control Technician
Carlow
Senior R&D Manager
Athlone
MS&T Associate Director
Dublin
R&D Engineer
Galway
Senior Quality Engineer
Limerick
Product Development Engineer
Galway
Senior R&D Engineer
Galway
Senior Associate Quality Control
Dublin
Project Engineer - Senior
Cavan
Senior R&D Engineer
Galway
Operational Excellence Specialist
Meath
Sourcing Specialist
Tipperary
Responsible Person (RP)
Republic of Ireland
Process Engineer (NPI)
Carlow
R&D Director
Galway
Senior Validation Engineer
Carlow
Technology Transfer Specialist (Technica
Cork
Product Development Engineer
Dublin
R&D Manager
Galway
R&D Manager
Connaught
Technical Life Cycle & Engineering M
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Associate Director Global Regulatory Aff
Cork
Senior Electronics Engineer
Dublin
Principal Software Engineer
Athlone
Quality Engineer
Galway
Engineering Shift Technician
Dublin
Senior Manufacting Engineer
Republic of Ireland
Production Operator
Meath
Senior Quality Engineer
Leitrim
Senior R&D Engineer
Dublin
Quality Specialist
Tipperary
R&D Director
Galway
R&D Manager
Galway
Production Operator
Dublin
Maintenance Reliability Engineer
Tipperary
Manufacturing Technician
Clare
Facilities Engineer
Carlow
Senior Regulatory Affairs Specialist
Athlone
Downstream Investigations Specialist
Dublin
Regulatory Affairs Associate
Cork
Chief Medical Officer
Dublin
Product Development Engineer
Galway
Senior R&D Engineer
Galway
R&D Engineer
Galway
Clinical Monitor
Dublin
Manufacturing Engineer
Galway
Operations Manager
Wexford
Staff R&D Engineer- Customer Focus
Dublin
Senior Process Development Scientist
Dublin
Senior Project Manager - Process Develop
Dublin
R&D Engineer
Clare
Cleaning Validation Specialist
Carlow
Quality Systems Manager
Dublin
Senior Regulatory Affairs Specialist
Athlone
Quality Control Technician
Carlow
Senior Technical Transfer Specialist
Cork
R&D Engineer
Galway
Injection Moulding Engineer
Leitrim
Senoior Specialist - MS&T
Dublin
Senior Analytical Scientist
Cork
R&D Engineer
Galway
Notified Body Product Assessor -Active D
Canada
Manufacturing Technician
Clare
Senior Recruitment Consultant
Republic of Ireland
Material Handler
Carlow
R&D Manager
Athlone
Manufacturing Engineer
Galway
Senior Quality Control Associate
Dublin South
Lead Maintenance Reliability Engineer
Westmeath
Production Operator
Carlow
Senior Design Quality Engineer
Dublin
Validation Engineer
Cork
Senior R&D Engineer
Galway
Senior Manufacturing Engineer - (NC,CAPA
Limerick
Technical Specialist - Process Support
Cork
Senior Validation Engineer
Limerick
Senior Regulatroy Affairs Specialsit
Galway
Electronic Engineer
Dublin
Quality Technician
Dublin
Associate QA Specialist (Shift)
Carlow
Lead Maintenance Reliability Engineer
Westmeath
Principal Process Development Engineer
Galway
Sr. Associate - Quality for Computer Sys
Cork
Quality Engineer
Galway
Senior Research and Development Engineer
Galway
Reliability Engineer
Tipperary
Quality Manager - NPI
Dublin
Senior R&D Engineer
Dublin
Project Manager - R&D
Galway
Associate Director - Clinical Regulatory
Cork
Process Development Engineer
Galway
Electronic Design Engineer
Galway
Project Manager
Galway
Senior Regulatory Affairs Specialist
Clare
Recruitment Consultant
Republic of Ireland
R&D Engineer
Dublin
Principal Instrumentation Engineer
Limerick
Commissioning and Qualification Engineer
Dublin
R&D Manager
Athlone
Senior R&D Manager
Athlone
Global Safety Senior Manager
Dublin
Biomedical Engineer
Dublin
Senior Project Engineer
Cavan
Clinical Research Associate
Cork
Product Development Engineer
Dublin
Senior Process Engineer
Cork
R&D Engineer
Galway
R&D Manager
Galway
Validation Engineer
Carlow
Clinical Research Program Manager
Galway
Senior R&D Project Manager
Galway
Manufacturing Engineer
Cork
Senior R&D Engineer
Clare
Project Enginer
Dublin South
Senior Quality Engineer
Leitrim
Compliance Engineer
Carlow
Principal Quality Engineer
Galway
Program Manager
Dublin
Account Manager UK and Ireland
Republic of Ireland
Product Lead
Dublin
Compliance Specialist
Carlow
Senior Regulatory Affairs Specialist
Westmeath
Senior Design Assurance Engineer
Galway
Senior Recruitment Consultant
Dublin
Senior Electronic Engineer
Dublin
Head of R&D
Galway
Technology Transfer Specialist
Cork
Associate Director - Global Core Labelin
Cork
Senior Regulatory Affairs Specialist
Athlone
Product Development Engineer II
Athlone
Senior Associate Quality Control
Dublin
Project Manager
Limerick
Senior Validation Engineer
Dublin
Manufacturing Technician
Clare
QC Instrumentation Engineer
Limerick
Engineering Business Manager
Dublin
Injection Molding Engineer
North Leinster
Senior R&D Engineer
Galway
Principal Engineer
Dublin
Senior Technical Scientist - Technical T
Cork
Facilities Engineer
Carlow
Senior Microbiologist
Republic of Ireland
QA Compliance Specialist
Carlow
Operations Specialist
Louth
Project Engineer
Republic of Ireland
Technical Transfer Specialist
Cork
Senior QC Associate
Dublin
Clinical Research Associate
Cork
Scientist (hybrid)
Meath
Senior QC 24/7 Shift
Dublin
E&I Turnover Engineer
Carlow
Manufacturing Engineer
Galway
Senior Technical Transfer Engineer
Cork
R&D Engineer
Galway
Quality Systems Specialist
Galway
Maintenance Reliability Engineer
Tipperary
CQV Lead
Tipperary
Validation Engineer
Athlone
Chemical Engineer
Tipperary
Strategic Automation Lead
Waterford
Principal Process Equipment Engineer
Dublin South
Investigation Lead
Dublin
Senior Recruitment Consultant
Republic of Ireland
Biomedical Engineer
Dublin
Manufacturing Project Engineer
Mayo
Warehouse Manager
Dublin
Senior Electronic Engineer
Dublin
Utilities Engineer - Black Utilities
Roscommon
Technical Transfer Specialist - Remote
Republic of Ireland
Injection Moulding Engineer
Athlone
R&D Director
Galway
Maintenance CMMS Engineer
Tipperary
QC Laboratory Technician
Carlow
Associate Director Global Regulatory Aff
Cork
Product Development Technician II
Galway
Senior Human Factors Engineer
Dublin
Quality Technical Services Manager - 12
Dublin
Senior Equipment Design Engineer
Dublin
Quality Engineer
Wexford
Downstream Manufacturing Engineer
Dublin
Production Operator
Carlow
R&D Manager
Connaught
Senior R&D Manager/Director
Dublin
Principal/Senior R&D Engineer Cathet
Galway
Technical Services Manager
Tipperary
Maintenance Engineer
Carlow
Project Manager - R&D
Galway
Quality Engineer
Athlone
Senior Project Engineer - Utilities
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Reliability Engineering Specialist
Louth
Business Manager (Pharma Chemicals)
Westmeath
Principal Equipment Engineer
Dublin
Senior R&D Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Clean Utilities Engineer
Cork
Senior Quality Engineer-Remote
Republic of Ireland
Project Manager - R&D
Galway
Quality Specialist
Dublin
Procurement Senior Specialist
Meath
R&D Technician
Galway
Validation Specialist - 50/50 remote
Carlow
Senior Quality Engineer
Galway
QA Engineer
Leitrim
Senior Design Engineer
Dublin
Upstream Manufacturing Process Specialis
Cork
Manufacturing Technician
Clare
R&D Manager
Connaught
Technical Transfer Lead
Dublin
Senior Process Engineer
Cork
Senior Recruitment Consultant
Cork
Senior QC Microbiology (24/7 Shift)
Dublin
Senior Regulatory Specialist
Cork
Quality Engineer
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