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
Connaught
Production Operator
Meath
Senior Recruitment Consultant
Republic of Ireland
Account Manager UK and Ireland
Republic of Ireland
Senior Design Assurance Engineer
Athlone
Sales/Customer Service Administrator
Clonmel
R&D Engineer
Galway
Senior Design Engineer
Dublin
Senior QC Microbiology (24/7 Shift)
Dublin
Design Assurance Program Manager
Galway
Senior Equipment Design Engineer
Dublin
R&D Manager
Galway
Investigation Lead
Dublin
Quality Engineer
Galway
R&D Engineer
Dublin
R&D Manager
Dublin
R&D Technician II
Galway
QA Manager
Canada
Medical Writer
Cork
Clean Utilities Engineer
Carlow
R&D Engineer
Galway
E&I Turnover Engineer
Carlow
MS&T Bioprocess Engineer
Meath
Staff R&D Engineer- Customer Focus
Dublin
R&D Director
Galway
Product Development Engineer
Dublin
Senior Design Engineer
Dublin
Technical Transfer Specialist
Cork
Compliance Specialist
Carlow
Biostatistician
Dublin City Centre
Injection Molding Engineer
North Leinster
Electronic Design Engineer
Galway
Product Development Engineer
Dublin
Senior Electronics Engineer
Dublin
Project Manager
Kildare
Quality Assurance Specialist (Shift)
Carlow
Biomedical Engineer
Dublin
Embedded Software Engineer
Dublin
Production Operator
Dublin
Safety & Environmental Specialist
Carlow
Senior R&D Engineer
Galway
Quality Technician
Dublin
Senior R&D Engineer
Clare
Technical Life Cycle & Engineering M
Galway
Senior Regulatory Affairs Specialist
Dublin
Senior Technical Transfer Engineer - Hyb
Carlow
R&D Engineer
Galway
Senior Operations Engineer
Galway
Lead Maintenance Reliability Engineer
Westmeath
Quality Control NPI Senior Associate
Dublin South
R&D Manager
Galway
Quality Engineer
Galway
QA Specialist (REMOTE)
Dublin
Quality Technician
Dublin
R&D Engineer
Galway
Advanced Technologies R&D Manager
Clare
Validation Specialist - 50/50 remote
Carlow
Senior R&D Engineer
Dublin
(Senior) Manufacturing Engineers - Globa
Limerick
Injection Molding Engineer
North Leinster
Senior Quality Engineer
Galway
Director of Regulatory Affairs
Galway
R&D Engineer
Galway
Senior R&D Engineer
Galway
Advanced Technologies Manager
Galway
Sr. Associate - Quality for Computer Sys
Cork
Staff Systems Engineer
Limerick
Senior Associate Quality Control
Dublin
Senior Quality Control Associate
Dublin South
Principal/Senior R&D Engineer Cathet
Galway
Senior Regulatory Affairs Specialist
Athlone
Business Systems Director
Louth
Manufacturing Engineer
Wexford
Quality Assurance Specialist (Shift)
Carlow
Engineering Shift Technician
Dublin
Quality Engineer
Galway
Senior Equipment Engineer
Dublin
NPI Process Engineer
Carlow
Senior Regulatory Affairs
Galway
Senior Regulatory Affairs Specialist
Clare
Supply Chain Senior Associate (hybrid)
Dublin
Product Development Manager
Galway
Quality Engineer
Galway
QA Engineer
Leitrim
Production Operator
Meath
Senior Quality Engineer
Leitrim
Manufacturing Project Engineer
Mayo
Territory Sales Specialist (Life Science
Belfast City
Project Engineer
Clare
Applications Scientist
Dublin
R&D Engineer
Galway
R&D Engineer
Galway
Senior Electronic Design Engineer
Dublin
Clinical Trial Quality Representative
Cork
Project/Process Engineer - Purification
Cork
R&D Engineer
Galway
Maintenance Technician
Kilkenny
Quality Manager
Galway
R&D Director
Galway
Cleaning Validation Specialist
Cork
Senior Recruitment Consultant
Republic of Ireland
Senior Validation Engineer
Carlow
Process Engineer
Galway
Electronic Engineering
Dublin
Manufacturing Engineer
Galway
Senior Equipment Design Engineer
Dublin
R&D Manager
Connaught
Chief Medical Officer
Dublin
Electronic Engineer
Dublin
R&D Engineer
Galway
Business Development Manager - Leinster
Dublin
Quality Engineer
Galway
Cleaning Validation Specialist
Cork
Manufacturing Technician
Clare
Regional Program Coordinator - Global Le
Dublin
R&D Manager
Athlone
Senior Electrical Engineer
Galway
Senior QC 24/7 Shift
Dublin
CTO
Galway
R&D Engineer
Galway
Technology Transfer Specialist
Meath
Design Assurance Engineer
Clare
Change Control SME
Cork
Head of R&D
Galway
Maintenance Reliability Engineer
Tipperary
Process Engineer
Cork
Quality Engineer
Athlone
Technical Administrator
Tipperary
Senior QC Associate - Cell Culture
Dublin South
Senior Human Factors Engineer
Dublin
Regulatory Affairs Associate
Cork
Manufacturing Technician
Clare
Clinical Research Associate
Cork
Electronic Engineer
Dublin
Electronic Engineer
Dublin
Manufacturing Project Engineer
Sligo
Senior Quality Engineer-Remote
Republic of Ireland
Senior Operations Engineer
Galway
Senior Electronics Engineer
Limerick
Process Development Engineer
Galway
Mechanical Design Engineer
Germany
R&D Manager
Galway
Senior R&D Engineer
Galway
R&D Manager
Athlone
Senior R&D Engineer
Clare
Quality Engineer
Galway
Injection Moulding Engineer
Athlone
Manufacturing Biotech Associate 24/7 Shi
Meath
Design Assurance Engineer
Galway
Quality Engineer
Athlone
Senior R&D Manager
Athlone
Senior Associate QC
Dublin
R&D Engineer
Dublin
Cleaning Validation Specialist
Carlow
Value Stream Team Leader / Production Su
Wexford
R&D Engineer
Clare
Quality Engineer
Galway
Electronic Engineer
Dublin
Medical Secretary
Cork
R&D Program Manager
Dublin
R&D Manager
Connaught
Quality Specialist
Dublin
Senior Quality Engineer
Dublin
Principal Heart Valves Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Senior Design Assurance Engineer
Galway
Senior Regulatory Specialist
Cork
R&D Engineer
Galway
Business Development Manager (Opticians)
Dublin
Process Chemist
Limerick
Senior Mechanical Engineer
Dublin
Project Manager
Kildare
Senior Analytical Scientist
Cork
Principal Scientist/Engineer Medical Dev
Dublin
Senior QC Microbiology
Dublin
R&D Manager
Galway
Senior Project Engineer
Cavan
Senior Procurement Associate
Limerick
Electronic Engineer
Dublin
Notified Body Product Assessor -Active D
Canada
QA Manager
Canada
Regulatory Affairs Specialist
Cork
Pharmacovigilance Manager (Remote)
Republic of Ireland
Facilities Engineer
Carlow
Principal Device Engineer
Dublin
Quality Engineer
Galway
Project Engineer
Cork
Quality Manager - Medical Devices
Limerick City
Senior Maintenance Technician
Roscommon
Quality Specialist & Deputy RP
Limerick
QA Operations Specialist (hybrid)
Meath
Responsible Person (RP)
Republic of Ireland
Quality Assurance Engineer
Longford
R&D Engineer
Galway
Principal Process Development Engineer
Dublin
EHS Specialist
Meath
Project Manager - R&D
Galway
Senior Process Development Engineer
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Product Development Engineer
Galway
R&D Manager
Galway
R&D Director
Galway
Principal Preclinical Scientist
Galway
R&D Manager
Connaught
Product Development Engineer II
Athlone
Principal Process Development Engineer
Galway
Reliability Engineer
Tipperary
R&D Project Manager
Galway
Quality Engineer
Galway
Regulatory Affairs Associate
Cork
Quality Specialist
Tipperary
Design Assurance Engineer
Galway
Senior Technical Transfer Specialist
Cork
Strategic Automation Lead
Waterford
Senior R&D Engineer
Dublin
Principal Software Engineer
Athlone
Project Manager - R&D
Galway
Senior R&D Engineer
Galway
Quality Engineer
Galway
Senior Quality Engineer
Dublin
Senior Manufacting Engineer
Republic of Ireland
R&D Engineer
Galway
Product Development Engineer
Galway
Senior Design Engineer
Dublin
Senior Engineering Manager
Limerick
Senior Quality Engineer
Leitrim
Quality Control Technician
Carlow
R&D Manager
Galway
Senior QC Associate
Dublin
R&D Manager
Galway
Project Manager Design Assurance
Galway
Quality Manager - NPI
Dublin
Production Operator
Meath
Quality Specialist
Clare
Senior Electronic Engineer
Dublin
Commisioning and Qualification Engineer
Cork
Principal R&D Engineer
Galway
QC Separation Analyst
Cork
Director of Quality Engineering
Limerick
Process Safety Specialist
Tipperary
CTO
Dublin
R&D Engineer
Galway
R&D Engineer
Galway
Senior Quality Engineer
Dublin
Senior R&D Manager
Athlone
Medical Secretary
Cork
Maintenance Technician
Carlow
Project Engineer
Limerick
Quality Technical Services Manager - 12
Dublin
Senior R&D Engineer
Galway
R&D Engineer
Galway
Design Assurance Program Manager
Galway
Product Development Engineer
Dublin
Software Design Assurance Engineer
Dublin
Design Assurance Engineer
Clare
Shift Technician (Injection Moulding)
Kildare
Quality Engineer
Athlone
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