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
Thomas Gallagher
Life Science

+353870612325
[email protected]
Connect with me on
Hot Science Jobs
Clinical Project Manager
Cork
R&D Engineer
Galway
Technical Administrator
Tipperary
R&D Engineer
Galway
Senior Regulatory Affairs
Galway
Process Engineer
Galway
Senior Design Engineer
Dublin
R&D Engineer
Galway
Senior Quality Engineer
Galway
Senior Quality Engineer
Leitrim
Senior Quality Engineer-Remote
Republic of Ireland
Chemical Engineer
Tipperary
Senior Product Development Engineer
Galway
Head of R&D
Galway
Maintenance Engineer
Cork
Senior R&D Engineer
Clare
Process Simulation Technical Engineer
Carlow
Electrical Engineer
Cork
E&I Turnover Engineer
Carlow
Engineering Projects Lead
Carlow
Quality Specialist
Tipperary
R&D Manager
Connaught
R&D Director
Galway
Principal/Senior R&D Engineer Cathet
Galway
VP of Operations
Dublin
Senior Validation Engineer
Dublin
Principal Instrumentation Engineer
Limerick
Technical Transfer Specialist - Remote
Republic of Ireland
Project Engineer
Limerick
Mechanical Technician - 2 Cycle
Carlow
Senior Associate Quality Control
Dublin
Senior Human Factors Engineer
Dublin
Manufacturing Engineer
Cork
Senior Project Manager - Electrical
Dublin
QC Laboratory Technician (shift)
Carlow
Principal R&D Engineer
Dublin
Project Enginer
Dublin South
R&D Manager
Athlone
Senior Equipment Design Engineer
Dublin
Lead Project Engineer
Carlow
Downstream Manufacturing Engineer
Dublin
Senior Project Equipment Engineer
Dublin
Senior Technical Transfer Specialist
Cork
Senior Human Factors Engineer
Dublin
Process Engineer (Shift)
Carlow
Senior Process Engineer
Dublin
Advanced Technologies R&D Manager
Clare
Technology Transfer Specialist
Cork
Manufacturing Technician
Clare
Chief Medical Officer
Dublin
MS&T Bioprocess Engineer
Meath
QA Compliance Specialist
Carlow
Quality Specialist
Tipperary
Senior Polymer Development Engineer
Galway
Cleaning Validation Specialist
Cork
Senior Associate QC
Dublin
Warehouse Manager
Dublin
Principal Software Engineer
Athlone
R&D Engineer
Dublin
Quality Specialist
Clare
Quality Engineer
Galway
Senior Regulatory Affairs Specialist
Clare
Quality Engineer
Galway
Buyer
Wexford
Quality Assurance Engineer
Longford
Product Development Engineer II
Athlone
Senior R&D Engineer
Dublin
Specialist Operations Engineer
Tipperary
Electronic Design Engineer
Galway
Procurement Senior Specialist
Meath
Quality Manager - NPI
Dublin
R&D Manager
Dublin
Senior Manufacturing Engineer - (NC,CAPA
Limerick
Project Manager
Limerick
Master Data Associate
Limerick
Process Development Engineer
Galway
Manufacturing Engineer
Limerick
Quality Technician
Dublin
Senior Microbiologist
Republic of Ireland
Quality Control Technician
Carlow
QC External Sample and Retain Coordinato
Carlow
Senior Technical Scientist - Technical T
Cork
Manufacturing Engineer
Wexford
CQV Lead
Tipperary
Manufacturing Technician
Clare
Operations Manager
Wexford
Technical Life Cycle & Engineering M
Galway
Technical Life Cycle & Engineering M
Galway
Quality Operations Manager
Dublin
E&I Turnover Engineer
Carlow
Quality and Regulatroy Manager
Galway
R&D Manager
Athlone
Process Engineer - Water Formulations
Limerick
Production Operator
Carlow
Director of Quality Engineering
Limerick
Project Engineer
Republic of Ireland
Compliance Engineer
Carlow
R&D Manager
Galway
Recruitment Consultant
Republic of Ireland
Senior Recruitment Consultant
Republic of Ireland
Senior Quality Engineer
Limerick
R&D Engineer
Clare
Senior Validation Engineer
Limerick
R&D Manager
Galway
Cleaning Validation Engineer
Carlow
QA Manager
Canada
Senior Design Engineer
Dublin
Materials Management Scientist
Limerick
Senior Microbiologist
Dublin
R&D Manager
Connaught
C&Q Lead
Tipperary
Process Engineer
Limerick
Project Engineer - Senior
Cavan
Technical Specialist - Manufacturing Pro
Cork
Senior R&D Engineer
Galway
Clinical Research Program Manager
Galway
Cleaning Validation Specialist
Carlow
Senior Quality Engineer
Dublin
R&D Senior Program Manager
Galway
QA Manager
Canada
Principal Process Development Engineer
Galway
R&D Director
Galway
R&D Engineer
Galway
Project Engineer
Roscommon
Remote Process Engineer - Fill Finish
Republic of Ireland
Quality Engineer
Wexford
Product Development Engineer II
Athlone
R&D Engineer
Galway
Senior Process Engineer
Cork
Sales/Customer Service Administrator
Clonmel
Validation Specialist - 50/50 remote
Carlow
Senior Project Engineer
Cavan
Program Manager
Cork
Senior Process Development Engineer
Galway
Senior Engineering Manager
Limerick
Medical Writer
Cork
R&D Engineer
Galway
R&D Technician II
Galway
R&D Engineer
Dublin
Senior Mechanical Engineer
Dublin
Senior Validation Engineer
Dublin
Business Manager (Pharma Chemicals)
Westmeath
Principal R&D Engineer
Dublin
R&D Manager
Connaught
R&D Engineer
Galway
Production Operator
Dublin
Regulatory Affairs Specialist
Cork
Instrument Specialist
Tipperary
CQV Engineer - SIP Start Up
Denmark
Maintenance CMMS Engineer
Tipperary
Process Support Specialist
Carlow
(Senior) Manufacturing Engineers - Globa
Limerick
Maintenance Reliability Engineer
Tipperary
Lead Maintenance Reliability Engineer
Westmeath
Biostatistician
Dublin City Centre
Project Engineer - Senior
Cavan
R&D Manager
Galway
Senior Electronic Engineer
Dublin
Sr. Associate - Quality for Computer Sys
Cork
EHS Specialist
Carlow
Cleaning Validation Specialist
Cork
Clean Utilities Engineer
Carlow
Injection Molding Engineer
North Leinster
Senior Manufacturing Engineer
Cork
R&D Engineer
Galway
R&D Program Manager
Dublin
Packaging Engineer
Dublin
Quality Manager
Dublin
Engineering Shift Technician
Dublin
Validation Specialist
Cork
Manufacturing Project Engineer
Sligo
Senior Quality Engineer
Leitrim
Software Design Assurance Engineer
Dublin
Product Development Manager
Galway
Senior Quality Engineer
Dublin
Account Manager UK and Ireland
Republic of Ireland
Technical Transfer Lead
Dublin
Senior Quality Control Associate
Dublin South
Process Chemist
Limerick
Scientist (hybrid)
Meath
Supply Chain Manager (hybrid)
Dublin
Senior Recruitment Consultant
Republic of Ireland
Suite Team Delivery Lead
Tipperary
Quality Control Technician
Carlow
Injection Moulding Engineer
Leitrim
Senior Project Engineer - Utilities
Dublin
Commissioning and Qualification Engineer
Dublin
Senior R&D Engineer-New Product Deve
Westmeath
Senior Manager Device Supplier Assurance
Dublin
Senior Equipment Design Engineer
Dublin
Clinical Affairs Specialist
Galway
Applications Scientist
Dublin
Product Lead
Dublin
Senior Quality Engineer
Dublin
Senior R&D Manager
Athlone
Quality Validation Engineer
Limerick
Maintenance CMMS Engineer
Tipperary
Biomedical Engineer
Dublin
QA Engineer
Leitrim
Facilities Engineer
Carlow
R&D Manager
Galway
Process Engineer
Cork
Lead Maintenance Reliability Engineer
Westmeath
Principal Device Engineer
Dublin
Product Development Technician II
Galway
Project/Process Engineer - Purification
Cork
R&D Manager
Connaught
Technical Transfer Specialist
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Project Manager - R&D
Galway
Senior R&D Engineer
Galway
Senior R&D Project Manager
Galway
Project Engineer
Tipperary
Commissioning, Qualification and Valid
Carlow
R&D Technician
Galway
Senior Process Engineer
Cork
Senior Electronic Design Engineer
Dublin
R&D Director
Galway
Senior Regulatory Affairs Specialist
Athlone
Scientist - Process Cleaning
Limerick
Manufacturing Technician
Clare
Quality Systems Manager
Dublin
Clinical Trial Quality Representative
Cork
Senior QC 24/7 Shift
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Senior Manufacting Engineer
Republic of Ireland
Injection Molding Engineer
North Leinster
Senior Operations Engineer
Galway
Clean Utilities Engineer
Cork
Senior Quality Engineer
Galway
Technical Specialist - Analytical &
Cork
Senior R&D Manager - Lifecycle Manag
Galway
Senior QC Associate
Dublin
Commissioning and Qualification Engineer
Cork
Associate Director Global Regulatory Aff
Cork
Senior Regulatroy Affairs Specialsit
Galway
Senior Design Assurance Engineer
Galway
Maintenance Planner
Westmeath
Senior Quality Engineer
Leitrim
Responsible Person (RP)
Republic of Ireland
Technical Transfer Specialist
Cork
Validation Engineer
Carlow
Quality Systems Specialist
Galway
Senior QC Microbiology (24/7 Shift)
Dublin
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 Specialist


Reference:TG - Reg Affairs - Galway Location: Athlone
Clare
Connaught
Galway
Galway City
Leitrim
Limerick
Limerick City
Longford
Mayo
Midlands
Offaly
Republic of Ireland
Roscommon
Sligo
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA RA Engineer, Regulatory Affairs Clinical Research, Regulatory Affairs Consultant, Regulatory Affairs Director, Regulatory Affairs Executive, Regulatory Affairs Manager, Regulatory Affairs Officer, Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist
Location: Parkmore, Galway. 1 day a week on site
Benefits: Top salary, Bonus, pension, healthcare, hybrid working



Overview:
My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. With a culture of innovation helping each individual develop both professionally and personally, and our culture of respect means that they all work in a collaborative, empowering, and exciting environment. Reporting to the Senior Regulatory Affairs Manager, the Senior Regulatory Affairs SpecialistPost Market will play a key role in the implementation of post-market activities. This is a fantastic opportunity, which will allow the successful candidate to add real value to the future success of the company.



Responsibilities:
- Responsible for the implementation of PMS activities identified under Post Market Regulatory Reporting and change assessment as defined in relevant Quality System procedures and Work Instructions.
- Approval of Vigilance/MDR reporting as defined in each territory.
- Support and lead Regulatory Post Market System improvements.
- Participate in the implementation of Field Safety Corrective Action plan and associated activities if required
- Manage RA activities for Design Changes and Supplier-related changes including reporting assessment and generation of regulatory submissions.
- Provide RA Support to relevant Design Teams for Key Projects identified by Veryan.
- Management of PMA Annual Periodic Reporting system and approval of annual documentation for submission to FDA.
- Manage post-market scheduling of RA activities for timely completion and submission to regulatory authorities.


Requirements:

  • A degree level qualification in Engineering, Science, QA, or related field is essential.
  • A minimum of 3 years experience at regulatory position in the medical device industry is essential.
  • Experience of FDA guidance for sterile implantable products in premarket approvals is desirable.
  • Technical competency of ISO13485:2016, ISO 14971, MDR 2017/745, and the FDA QSRs is a prerequisite.


Does this sound like your next career move? To apply and For more info forward your application to the link provided or contact me on 087 0612325 OR [email protected]