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
Lead Project Engineer
Carlow
Design Assurance Program Manager
Galway
Senior Validation Engineer
Carlow
Quality Technician
Dublin
Product Development Manager
Galway
R&D Manager
Athlone
QA Manager
Canada
Validation & Verification Engineer
Dublin
Head of R&D
Galway
Embedded Software Engineer
Dublin
Senior Design Assurance Engineer
Clare
Project Manager - R&D
Galway
R&D Manager
Galway
Technical Specialist - Manufacturing Pro
Cork
Cleaning Validation Specialist
Carlow
Principal Heart Valves Engineer
Galway
Senior Process Development Engineer
Galway
Principal Quality Engineer
Galway
Process Chemist
Limerick
Maintenance Reliability Engineer
Tipperary
Manufacturing Technician
Clare
Account Manager UK and Ireland
Republic of Ireland
Product Development Technician II
Galway
(Senior) Manufacturing Engineers - Globa
Limerick
Senior Electronic Design Engineer
Dublin
Quality Assurance Specialist (Shift)
Carlow
Quality Technician
Dublin
Maintenance CMMS Engineer
Tipperary
Value Stream Team Leader / Production Su
Wexford
Staff R&D Engineer- Customer Focus
Dublin
Senior R&D Engineer
Galway
R&D Director
Galway
DeltaV Lead Automation Engineer
Tipperary
Senior Quality Engineer
Dublin
Design Assurance Engineer
Clare
Product Development Engineer
Galway
Senior Human Factors Engineer
Dublin
Senior R&D Engineer
Galway
R&D Engineer
Galway
Project Engineer
Limerick
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Associate QC
Dublin
R&D Manager
Galway
Senior Quality Engineer
Leitrim
Regulatory Affairs Specialist
Cork
Senior Design Assurance Engineer
Galway
R&D Manager
Connaught
Electronic Engineering
Dublin
Project Manager - R&D
Galway
Clean Utilities Engineer
Carlow
Process Engineer
Cork
Senior Design Assurance Engineer
Athlone
Biostatistician
Dublin City Centre
Senior Regulatory Affairs Specialist
Athlone
Principal/Senior R&D Engineer Cathet
Galway
Senior Analytical Specialist
Limerick
EHS Specialist
Meath
Commisioning and Qualification Engineer
Cork
Senior R&D Manager/Director
Dublin
QC Laboratory Technician (shift)
Carlow
Scientist (hybrid)
Meath
Associate QA Specialist (Shift)
Carlow
Senior R&D Engineer
Galway
Senior R&D Engineer
Dublin
Principal Data Architect
Limerick
Principal Process Development Engineer
Galway
R&D Engineer
Galway
Principal Engineer
Dublin
Technical Life Cycle & Engineering M
Galway
Quality Specialist
Clare
R&D Engineer
Galway
Product Development Engineer
Dublin
Director of Regulatory Affairs
Galway
EHS Officer
Dublin
Manufacturing Engineer
Galway
Lead Chemistry Analyst
Cork
R&D Manager
Connaught
MS&T Associate Director
Dublin
Injection Molding Engineer
North Leinster
Senior Project Engineer
Cavan
Shift Technician (Injection Moulding)
Kildare
R&D Engineer
Galway
Production Operator
Carlow
Electronic Engineer
Dublin
Senior R&D Engineer
Galway
Electronic Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
R&D Director
Galway
Senior Associate Quality Control
Dublin
Associate Director - Global Core Labelin
Cork
QA Manager
Canada
Production Operator
Dublin
Quality Engineer
Athlone
Technical Transfer Specialist
Cork
Engineering Projects Lead
Carlow
E&I Turnover Engineer
Carlow
Senior Manufacting Engineer
Republic of Ireland
Quality Systems Manager
Dublin
R&D Engineer
Galway
Technology Transfer Specialist
Meath
R&D Manager
Galway
Senior Equipment Design Engineer
Dublin
Process Engineer
Galway
Quality Engineer
Galway
R&D Engineer
Dublin
Quality Control Technician
Carlow
R&D Engineer
Galway
Senior Quality Engineer-Remote
Republic of Ireland
Senior Quality Engineer
Leitrim
Manufacturing Engineer
Cork
Senior R&D Engineer
Galway
Validation Engineer
Athlone
Senior Research and Development Engineer
Galway
Injection Moulding Engineer
Athlone
Regional Program Coordinator - Global Le
Dublin
Senior R&D Project Manager
Galway
Quality Manager
Dublin
R&D Engineer
Galway
Manufacturing Technician
Clare
Senior Manager Clinical Quality
Cork
Operations Engineer
Galway
Medical Writer
Cork
Principal R&D Engineer
Galway
Injection Moulding Engineer
Athlone
Senior Process Engineer
Dublin
QC Systems Specialist
Dublin
Senior Associate Quality Control NPI
Dublin
Principal Engineer - R&D
Galway
Senior R&D Engineer
Clare
Manufacturing Engineer
Wexford
Senior Manager Bioanalytical QC Lab
Limerick
R&D Engineer
Galway
Senior Operations Engineer
Galway
Facilities Engineer
Carlow
Injection Moulding Engineer
Leitrim
Maintenance Reliability Engineer
Cork
Project Manager
Galway
Process Safety Specialist
Tipperary
Program Manager
Dublin
Quality Engineer
Galway
Senior Operations Engineer
Galway
Biomedical Engineer
Dublin
Mechanical Technician - 2 Cycle
Carlow
Senior Regulatroy Affairs Specialsit
Galway
Quality Engineer
Galway
Project Engineer
Clare
Senior R&D Manager - Lifecycle Manag
Galway
Senior R&D Engineer
Galway
Senior Director Statistics Data and Anal
Cork
Senior R&D Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Quality Specialist & Deputy RP
Limerick
Applications Scientist
Dublin
Manufacturing Technician
Clare
Senior QC Associate
Dublin
Quality Engineer
Galway
Senior Equipment Design Engineer
Dublin
Clinical Trial Quality Representative
Cork
Senior Regulatory Specialist
Cork
SAP Analyst - Logistics & Supply Cha
Limerick
Responsible Person (RP)
Republic of Ireland
R&D Director
Galway
Manufacturing Engineer
Galway
Project Engineer
Roscommon
Senior Analytical Scientist
Cork
Senior Regulatory Affairs Specialist
Dublin
Quality Operations Manager
Dublin
Senior Technical Transfer Engineer - Hyb
Carlow
Technical Administrator
Tipperary
R&D Engineer
Galway
R&D Manager
Connaught
Senior Quality Engineer
Galway
Senior QC Microbiology (Shift)
Dublin
Engineering Shift Technician
Dublin
NPI Process Engineer
Carlow
Manufacturing Project Engineer
Mayo
Microbiology Manager
Dublin
Senior Quality Engineer
Dublin
R&D Engineer
Galway
Quality Technical Services Manager - 12
Dublin
Senior Quality Engineer
Dublin
QC Bioanalytical Analyst
Dublin North
Senior R&D Manager - Lifecycle Manag
Galway
Microbiologist
Cork
R&D Manager
Athlone
Quality Control Technician
Carlow
Manufacturing Engineer
Galway
Advanced Technologies R&D Manager
Clare
Senior Validation Engineer
Dublin
Quality Systems Specialist
Tipperary
Project Scheduler
Louth
Senior Design Engineer
Dublin
R&D Manager
Dublin
R&D Manager
Connaught
Senior Recruitment Consultant
Republic of Ireland
QA Engineer
Leitrim
Product Development Engineer II
Athlone
Quality Assurance Engineer
Longford
Upstream Manufacturing Process Specialis
Cork
Electronic Design Engineer
Galway
R&D Engineer
Dublin
Quality Manager - Medical Devices
Limerick City
Quality Engineer
Galway
Project Manager Design Assurance
Galway
Quality Specialist
Tipperary
Senior R&D Engineer
Clare
Quality Manager - NPI
Dublin
Cleaning Validation Specialist
Cork
Senior Design Engineer
Dublin
Mechanical Design Engineer
Germany
R&D Program Manager
Dublin
R&D Engineer
Galway
Project/Process Engineer - Purification
Cork
Technical Transfer Specialist - Remote
Republic of Ireland
R&D Engineer
Galway
Senior Human Factors Engineer
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Project Engineer
Cork
Quality and Regulatroy Manager
Galway
Biomedical Engineer
Dublin
CTO
Dublin
Quality Engineer
Galway
Electronic Engineer
Dublin
Injection Molding Engineer
North Leinster
Senior Quality Engineer
Dublin
Senior Quality Systems Engineer
Galway
Regulatory Affairs Associate
Cork
R&D Engineer
Galway
Senior Electronic Engineer
Dublin
Quality Manager
Wexford
R&D Senior Program Manager
Galway
Reg Affairs Specialist
Connaught
Maintenance Technician
Carlow
Senior Electronics Engineer
Dublin
CTO
Galway
R&D Engineer
Clare
Senior R&D Engineer
Dublin
R&D Engineer
Galway
Quality Engineer
Galway
Cleaning Validation Specialist
Cork
R&D Manager
Galway
Process Simulation Technical Engineer
Carlow
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 - SRA Post Market Location: Athlone
Clare
Connaught
Galway
Galway City
Leitrim
Limerick
Limerick City
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Specialist, Regulatory Affairs, Regulatory Affairs Clinical Research, Regulatory Affairs Consultant, Regulatory Affairs Crop Protection, Regulatory Affairs Director, Regulatory Affairs Executive, Regulatory Affairs Manager

Job title: Senior Regulatory Affairs Specialist – Post market
Location: Parkmore, Galway. 1-2 days 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.
- Provide support to other RA Specialists in achieving success for the team.
- Manage and support trend data for regulatory reporting.
- 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.
- Review and approval of RA QMS procedures and work instructions and ensure activities are performed in line with these.


Requirements:

  • A degree level qualification in Engineering, Science, QA, or related field is essential.
  • A minimum of five years experience at a senior regulatory level in the medical device industry is essential.
  • A minimum of five years’ experience in the creation of regulatory submissions for premarket approval is required.
  • 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]