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
Cleaning Validation Specialist
Cork
Clinical Trial Quality Representative
Cork
Senior Process Engineer
Cork
Notified Body Product Assessor -Active D
Canada
Manufacturing Project Engineer
Mayo
Validation & Verification Engineer
Dublin
R&D Manager
Galway
Technology Transfer Specialist
Meath
Suite Team Delivery Lead
Tipperary
Senior Quality Engineer
Dublin
Senoior Specialist - MS&T
Dublin
Downstream Manufacturing Engineer
Dublin
Design Assurance Program Manager
Galway
Quality Assurance Engineer
Longford
R&D Director
Galway
Electronic Engineer
Dublin
Production Operator
Meath
Project Manager
Limerick
Buyer
Wexford
Senior Project Manager - Process Develop
Dublin
Cleaning Validation Specialist
Cork
Quality Engineer
Wexford
Senior Regulatory Affairs Specialist
Athlone
Product Development Manager
Galway
Product Development Manager
Galway
Quality Technician
Dublin
Senior Equipment Design Engineer
Dublin
Senior Technical Scientist - Technical T
Cork
Product Development Engineer
Dublin
Maintenance Engineer
Cork
Regulatory Affairs Associate
Cork
R&D Engineer
Galway
National Retail Sales Manager (Ireland)
Dublin
R&D Technician II
Galway
Production Operator
Carlow
QA Associate Specialist - Shift
Carlow
Senior Design Assurance Engineer
Galway
Process Development Engineer
Galway
Senior R&D Engineer
Dublin
Senior Validation Engineer
Limerick
Senior Microbiologist
Republic of Ireland
Manufacturing Technician
Clare
Scientist (hybrid)
Meath
R&D Director
Galway
R&D Manager
Dublin
Manufacturing Technician
Clare
Change Control Coordinator
Carlow
Shift Technician (Injection Moulding)
Kildare
Engineering Business Manager
Dublin
Senior R&D Engineer
Galway
R&D Manager
Connaught
Quality Technical Services Manager - 12
Dublin
Advanced Technologies Manager
Galway
Senior Human Factors Engineer
Dublin
Technical Specialist - Process Support
Cork
Technical Life Cycle & Engineering M
Galway
Senior Electronics Engineer
Dublin
Cleaning Validation Specialist
Cork
Senior R&D Engineer-New Product Deve
Westmeath
R&D Engineer
Galway
Technology Transfer Specialist (Technica
Cork
Quality and Regulatroy Manager
Galway
Process Engineer (Shift)
Carlow
R&D Engineer
Galway
R&D Manager
Connaught
Maintenance Reliability Engineer
Cork
Maintenance Engineer
Cork
Senior Validation Engineer
Dublin
Quality Manager
Galway
Project Manager
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Senior Regulatory Specialist
Cork
Head of R&D
Galway
Maintenance CMMS Engineer
Tipperary
Principal R&D Engineer
Dublin
Product Development Engineer II
Athlone
Regional Program Coordinator - Global Le
Dublin
Product Development Engineer
Dublin
Project Engineer
Roscommon
Senior R&D Project Manager
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Lead Maintenance Reliability Engineer
Westmeath
Senior R&D Engineer
Dublin
Clinical Monitor
Dublin
Injection Moulding Engineer
Athlone
Validation Engineer
Limerick
Responsible Person (RP)
Republic of Ireland
Clean Utilities Engineer
Carlow
Senior Associate Quality Control NPI
Dublin
QC Instrumentation Engineer
Limerick
Product Development Technician II
Galway
Account Manager UK and Ireland
Republic of Ireland
Quality Engineer
Galway
Validation Specialist
Cork
Manufacturing Engineer
Cork
Global Safety Senior Manager
Dublin
Senior Quality Engineer
Dublin
Project Manager - R&D
Galway
Manufacturing Engineer
Galway
Recruitment Consultant
Republic of Ireland
Aseptic Process Lead
Carlow
Injection Molding Engineer
North Leinster
Senior Equipment Design Engineer
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
Sales Account Manager, EMEA (Medical Dev
Dublin
Product Development Engineer
Dublin
R&D Technician II
Galway
R&D Director
Galway
Senior Associate Buyer
Dublin
Sr. Associate - Quality for Computer Sys
Cork
Downstream Investigations Specialist
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Mechanical Technician - 2 Cycle
Carlow
Technical Transfer Specialist
Cork
Senior Recruitment Consultant
Dublin
Quality Specialist
Tipperary
Quality Specialist
Clare
R&D Manager
Connaught
Senior Design Assurance Engineer
Galway
Utilities Engineer - Black Utilities
Roscommon
Senior Maintenance Technician
Roscommon
Quality Validation Engineer
Limerick
Principal Engineer
Dublin
Quality Specialist
Clare
R&D Engineer
Galway
R&D Engineer
Clare
Principal R&D Engineer
Galway
Project Manager - R&D
Galway
Maintenance Technician
Carlow
CQV Lead
Tipperary
Process Engineer
Limerick
Commisioning and Qualification Engineer
Cork
Senior Validation Engineer
Carlow
Manufacturing Technician
Clare
Change Control SME
Cork
Senior Polymer Development Engineer
Galway
Quality Control Technician
Carlow
Senior Design Quality Engineer
Dublin
Mechanical Design Engineer
Germany
Injection Molding Engineer
North Leinster
R&D Manager
Athlone
Senior Regulatory Affairs
Galway
Principal Equipment Engineer
Dublin
Process Engineer (NPI)
Carlow
Principal Engineer
Dublin
Injection Moulding Engineer
Athlone
E&I Turnover Engineer
Carlow
Senior Equipment Design Engineer
Dublin
Project Manager - Capital Projects
Meath
Senior Quality Engineer
Limerick
Principal Preclinical Scientist
Galway
Senior R&D Engineer
Galway
Product Development Engineer II
Athlone
R&D Lifecycle Manager
Connaught
QA Engineer
Leitrim
Senior R&D Engineer
Dublin
Quality Specialist
Tipperary
Senior Director Statistics Data and Anal
Cork
Senior Validation Engineer
Dublin
Process Chemist
Limerick
Senior Maintenance Technician
Carlow
R&D Engineer
Galway
Quality Manager - NPI
Dublin
R&D Engineer
Galway
Quality Engineer
Athlone
MS&T Associate Director
Dublin
Principal R&D Engineer
Galway
Engineering Shift Technician
Dublin
Facilities Engineer
Carlow
Senior Electrical Engineer
Galway
Senior Clinical Project Manager
Dublin
Product Development Engineer
Dublin
Project Enginer
Dublin South
Project Engineer
Clare
Associate Director - Global Core Labelin
Cork
Technical Sales Manager (Chemistry)
Westmeath
Clean Utilities Engineer
Cork
Senior R&D Engineer
Galway
Facilities Engineer
Carlow
E&I Turnover Engineer
Carlow
Senior Validation Engineer
Dublin
R&D Engineer
Dublin
Principal Quality Engineer
Galway
Clinical Research Program Manager
Galway
Senior QC Associate
Dublin
Supply Chain Manager (hybrid)
Dublin
Director of Quality Engineering
Limerick
Embedded Software Engineer
Dublin
Quality Specialist
Dublin
Senior Operations Engineer
Galway
Senior Manufacting Engineer
Republic of Ireland
Senior R&D Manager - Lifecycle Manag
Galway
Principal Process Development Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Senior Microbiology Specialist - Greece
Republic of Ireland
Biostatistician
Dublin City Centre
Regulatory Affairs Specialist
Cork
Cleaning Validation Specialist
Carlow
R&D Engineer
Galway
Project Engineer
Tipperary
Quality Operations Manager
Dublin
Associate QA Specialist (Shift)
Carlow
Quality Engineer
Athlone
Regulatory Affairs Associate
Cork
R&D Engineer
Dublin
Senior Quality Engineer
Galway
Associate Director Global Regulatory Aff
Cork
Maintenance CMMS Engineer
Tipperary
Project Engineer
Republic of Ireland
QC Separation Analyst
Cork
R&D Manager
Galway
QA Manager
Canada
Quality Engineer
Galway
Senior Process Development Scientist
Dublin
Warehouse Manager
Dublin
Senior Equipment Engineer
Dublin
Senior Regulatory Specialist
Cork
Lead Chemistry Analyst
Cork
R&D Engineer
Galway
R&D Manager
Athlone
Manufacturing Technician
Clare
Senior Electronic Engineer
Dublin
Process Engineer
Galway
Quality Specialist
Clare
Senior Research and Development Engineer
Galway
Technology Transfer Specialist
Cork
Process Validation Engineer
Cork
Instrument Specialist
Tipperary
QA Manager
Canada
Senior Human Factors Engineer
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Senior R&D Engineer
Galway
Compliance Engineer
Carlow
Sourcing Specialist
Tipperary
Process Support Specialist
Carlow
Technical Transfer Specialist
Dublin
Material Handler
Carlow
Production Operator
Meath
Project Engineer
Limerick
Manufacturing Biotech Associate 24/7 Shi
Meath
Senior Process Engineer
Cork
Strategic Automation Lead
Waterford
Operations Specialist
Louth
R&D Manager
Galway
Operational Excellence Specialist
Meath
Senior R&D Manager/Director
Dublin
Quality Engineer
Athlone
R&D Manager
Galway
Quality Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Technical Specialist - Manufacturing Pro
Cork
Principal Process Development Engineer
Galway
R&D Engineer
Galway
Senior R&D Engineer
Dublin
Lead Maintenance Reliability Engineer
Westmeath
Manufacturing Engineer
Galway
Chemical Engineer
Tipperary
Project Manager - R&D
Galway
C&Q Lead
Tipperary
Product Development Engineer
Galway
Product Lead
Dublin
R&D Manager
Connaught
Business Manager (Pharma Chemicals)
Westmeath
QC External Sample and Retain Coordinato
Carlow
Clinical Research Associate
Cork
Technical Transfer Engineer - Drug Subst
Louth
Principal Process Equipment Engineer
Dublin South
Senior Project Engineer
Cavan
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 - Senior RA Location: Clare
Connaught
Galway
Galway City
Limerick
Limerick City
Mayo
Roscommon
Sligo
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: CMC Regulatory Affairs, Lead Quality Engineer, QA RA Engineer, Regulatory Affairs, Regulatory Affairs Clinical Research, Regulatory Affairs Consultant, Regulatory Affairs Director, Regulatory Affairs Executive

Job title: Senior Regulatory Affairs Specialist – Premarket
Location: Parkmore, Galway. 1-2 days a week on site
Benefits: Top salary, Bonus, pension, healthcare, hybrid working


Company:
My client are a fast-paced, rapidly growing medical device company offering a highly differentiated solution in vascular interventions. This role is best suited to an individual who is self-motivated, accountable and seeking infinite learning and growth opportunities.



Role:
As a Senior Regulatory Affairs Specialist you will will play a key role in supporting pre-market approval applications for their products across international markets. This is a fantastic opportunity, which will allow you to add real value to the future success of the company while working as part of a supportive, collaborative team in the new state-of-the-art facility in Galway. Work directly with R&D and Design Assurance throughout the full product lifecycle also work directly with regulatory authorities.



Responsibilities:

  • Compile international regulatory submissions for Veryan products under development, as required.
  • Adhere to regulatory submission timelines, identify risks and appropriate mitigations.
  • Review data intended for submission in international regulatory applications, identify gaps and make recommendations.
  • Participate in risk management activities for designated projects.
  • Provide regulatory input during the design control process of development projects at every design phase.
  • Review and contribute to regulatory aspects of change control, labelling changes etc. during premarket development projects.
  • Review and contribute to clinical evaluation reporting activities, and participate on clinical operations projects e.g. clinical investigation protocols.
  • Work within the quality system and ensure that the quality policy and company systems and procedures are complied with in line with the MDR 2017/745, and FDA Quality System Regulations 21 CFR Part 820 and ISO 14971.
  • Work with project management on project planning activities.
  • Identify opportunities for improvement within the RA department.
  • Support Regulatory team members with training as required.
  • Support Veryan Quality System activities as required.




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.
  • Excellent attention to detail and ability to produce reports at a high standard.
  • Proven skills in the area of communication, organisation, computer literacy, problem solving and collaboration.
  • Ability to work independently, with minimal supervision and use own initiative to respond to any issues arising.


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]