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
Senior Design Engineer
Dublin
Project Manager - Capital Projects
Meath
Facilities Engineer
Carlow
R&D Manager
Galway
(Senior) Manufacturing Engineers - Globa
Limerick
Senior Recruitment Consultant
Republic of Ireland
Quality Systems Manager
Dublin
Senior Manufacturing Engineer
Cork
Senior R&D Manager - Lifecycle Manag
Galway
Quality Engineer
Wexford
Principal Process Equipment Engineer
Dublin South
Quality Control Technician
Carlow
Senior R&D Manager
Athlone
Senior Electrical Engineer
Galway
Senior Electronic Design Engineer
Dublin
Associate Supply Chain Import/Export Spe
Dublin
C&Q Lead
Tipperary
Process Engineer - Water Formulations
Limerick
Project Manager - R&D
Galway
Senior Operations Engineer
Galway
Senior QA Specialist - Compliance and Qu
Meath
Manufacturing Specialist - Investigation
Dublin South
Senior Validation Engineer
Cork
Quality - Tech Transfer Specialist
Cork
Senior Research and Development Engineer
Galway
Manufacturing Engineer
Cork
Production Operator
Carlow
Manufacturing Project Engineer
Mayo
Manufacturing Engineer
Cork
Quality Engineer
Athlone
Senior Reg Affairs Specialist - Post Mar
Galway
Electrical Engineer
Limerick
Process Engineer (Shift)
Carlow
Electrical Engineer
Cork
Validation Engineer
Athlone
Project Engineer
Roscommon
QA Engineer
Leitrim
Senior Manufacturing Engineer - (NC,CAPA
Limerick
Quality and Regulatroy Manager
Galway
Project Engineer
Cork
R&D Technical Life Cycle & Engin
Galway
Product Development Engineer
Dublin
Validation & Verification Engineer
Dublin
Technical Transfer Engineer - Drug Subst
Louth
Senior Quality Assurance Specialist
Dublin
Manufacturing Technician
Clare
Senior Regulatory Affairs Specialist
Clare
Process Engineer
Limerick
Clinical Research Physician (CRP) and He
Cork
Head of R&D
Galway
Quality Technician
Dublin
Injection Molding Engineer
North Leinster
QA Specialist - Validation and NPI
Carlow
Project Enginer
Dublin South
Maintenance CMMS Engineer
Tipperary
Senior Regulatory Affairs Specialist
Westmeath
QC Laboratory Technician (shift)
Carlow
Clinical Research Program Manager
Galway
R&D Engineer
Galway
Senior Mechanical Engineer
Dublin
Senior R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
Senior Electronic Engineer
Dublin
R&D Engineer
Clare
Advanced Technologies Manager
Galway
Cleaning Validation Specialist
Cork
Technical Transfer Specialist
Dublin
Project Engineer
Tipperary
Product Development Engineer
Galway
R&D Project Manager
Galway
Project Manager - R&D
Galway
Senior Utility Project Engineer
Dublin
Validation Engineer
Limerick
Senior Project Manager - Electrical
Dublin
E&I Turnover Engineer
Carlow
Senior R&D Engineer
Galway
Senior Quality Engineer
Dublin
Product Development Engineer
Galway
Operational Excellence Specialist
Meath
Senior Electronic Engineer
Dublin
Biomedical Engineer
Dublin
Quality Control NPI Senior Associate
Dublin South
Quality Specialist
Tipperary
Senior R&D Engineer
Clare
QC Separation Analyst
Cork
Senior R&D Engineer
Dublin
Senior Recruitment Consultant
Dublin
Quality Technician
Dublin
Commisioning and Qualification Engineer
Cork
Shift Technician (Injection Moulding)
Kildare
CQV Lead
Tipperary
Principal Quality Engineer
Galway
Scientist (hybrid)
Meath
Senior Quality Engineer-Remote
Republic of Ireland
Process Development Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior R&D Manager
Athlone
Senior QC Associate
Dublin
R&D Manager
Connaught
Sourcing Specialist
Tipperary
R&D Manager
Connaught
Senior Equipment Design Engineer
Dublin
Project Manager - R&D
Galway
Quality Engineer
Athlone
Sr. Associate - Quality for Computer Sys
Cork
Manufacturing Technician
Clare
Account Manager UK and Ireland
Republic of Ireland
Project Manager
Limerick
R&D Director
Galway
R&D Manager
Galway
Technical Quality Assurance Specialist
Dublin
Senior Quality Engineer
Limerick
Quality Specialist
Clare
Senoior Specialist - MS&T
Dublin
Engineering Shift Technician
Dublin
Quality Manager / PRRC
Dublin
R&D Manager
Galway
Principal R&D Engineer
Dublin
Quality Auditor (Systems Specialist)
Tipperary
Senior Recruitment Consultant
Republic of Ireland
Advanced Technologies R&D Manager
Clare
Maintenance Engineer
Cork
Supply Chain Process Lead
Louth
R&D Director
Galway
Lead Maintenance Reliability Engineer
Westmeath
Senior Regulatory Affairs Specialist
Athlone
Specialist Operations Engineer
Tipperary
Business Development Executive
England
Senior Quality Control Associate
Dublin South
Senior Technical Scientist - Technical T
Cork
QA Manager
Canada
Project Engineer
Limerick
QC Bioassay Analyst
Carlow
Senior Design Engineer
Dublin
Product Lead
Dublin
R&D Manager
Galway
Responsible Person (RP)
Republic of Ireland
Process Chemist
Limerick
Suite Team Delivery Lead
Tipperary
Senior Quality Engineer
Leitrim
R&D Engineer
Galway
Embedded Software Engineer
Dublin
Supply Chain Import / Export Specialist
Dublin
CQV Engineer (CIP Start Up)
Denmark
Quality Engineer
Athlone
Senior Equipment Design Engineer
Dublin
Product Development Engineer II
Athlone
Senior R&D Manager - Lifecycle Manag
Galway
R&D Manager
Athlone
Clean Utilities Engineer
Carlow
QA Manager
Canada
Senior Equipment Engineer
Dublin
Operations Lead
Dublin
Product Development Technician II
Galway
R&D Director
Galway
Production Operator
Carlow
R&D Engineer
Clare
Validation Engineer
Carlow
Senior Regulatory Affairs Specialist
Dublin
Senior Project Engineer
Cavan
Senior E&I Maintenance Technician
Carlow
Project Process Engineer
Carlow
QC Associate Microbiology Specialist
Carlow
Manager R&D
Connaught
Senior Manufacting Engineer
Republic of Ireland
Lead Chemistry Analyst
Cork
Production Operator
Carlow
Senior R&D Manager - Lifecycle Manag
Galway
Compliance Specialist
Carlow
QC Laboratory Technician
Carlow
Associate Director Global Regulatory Aff
Cork
Associate Director Clinical Development
Cork
Senior R&D Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Senior Regulatory Affairs
Galway
Validation Specialist
Cork
Recruitment Consultant
Republic of Ireland
Regional Program Coordinator - Global Le
Dublin
Engineering Business Manager
Dublin
Injection Molding Engineer
North Leinster
Remote Process Engineer - Fill Finish
Republic of Ireland
Process Microbiologist
Cork
Senior Recruitment Consultant
Cork
Manufacturing Biotech Associate 24/7 Shi
Meath
Regulatory Affairs Specialist
Cork
R&D Engineer
Galway
NPI Process Engineer
Carlow
Technology Transfer Specialist (Technica
Cork
R&D Director
Galway
Senior Quality Engineer
Dublin
Clean Utilities Engineer
Carlow
Principal Software Engineer
Athlone
R&D Engineer
Dublin
R&D Engineer
Galway
Senior Product Development Engineer
Galway
NPI Process Engineer
Carlow
Electronic Design Engineer
Galway
Senior Validation Engineer
Carlow
Process Support Specialist
Carlow
Senior QC 24/7 Shift
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Principal Heart Valves Engineer
Galway
R&D Lifecycle Manager
Connaught
R&D Manager
Connaught
Strategic Automation Lead
Waterford
Senior Electronics Engineer
Dublin
Validation Engineer
Cork
R&D Engineer
Galway
Quality Systems Specialist
Cork
Senior Quality Engineer
Dublin
Facilities Engineer
Carlow
Senior Validation Engineer
Limerick
Project Engineer
Republic of Ireland
Senior HVAC Engineer
Dublin
Commissioning and Qualification Engineer
Cork
Commissioning and Qualification Engineer
Dublin
EHS Specialist
Carlow
Chemical Engineer
Tipperary
Microbiologist
Louth
Product Development Engineer
Galway
Biostatistician
Dublin City Centre
Senior Design Quality Engineer
Dublin
Product Development Engineer II
Athlone
Material Handler
Carlow
R&D Engineer
Dublin
Quality Manager
Dublin
Injection Moulding Engineer
Athlone
R&D Manager
Connaught
Senior R&D Engineer
Galway
Principal R&D Engineer
Galway
R&D Engineer
Galway
R&D Technician II
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

Regulatory Affairs Specialist


Reference:JCAO1208 Location: Cork
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs, Regulatory Affairs Executive, Regulatory Affairs Specialist

Regulatory Affairs Specialist (Remote/Hybrid)



Our client a high potential start up medical device company currently seeks a Regulatory Affairs Specialist to join their team. Reporting to the Clinical and Regulatory Affairs Manager, the Regulatory Specialist will be responsible for helping with compliance to standards, regulatory submissions and annual reporting to the notified body and FDA. The Regulatory Affairs Specialist must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. This position requires an enthusiastic self-starter with a willingness to be a “hands-on” contributor. Excellent organisational skills, ability to balance immediate vs. long term priorities and strong multi-tasking skills are a necessity. An ability to work in a flexible and small entrepreneurial environment is essential and there is an excellent package available for the right candidate.



Role/Responsibilities:

  • Work closely with the QA Manager to ensure the effectiveness of the QMS to regulations
  • Managing day-to-day regulatory activities as well as handling multiple projects related to product and compliance enhancements.
  • Work closely with the QA Manager for notified body audits and other audits as required.
  • Assist in the migration from MDD to MDR within the organisation.
  • Support the wider team to ensuring product manufacture and testing meets the requirements of both CE mark and FDA submissions.
  • Work with the organisation’s suppliers to ensure the products’ process validations and risk management files are to the standard of regulatory submissions.
  • Provide strategic regulatory insight to team members regarding product development plans
  • Work with the Commercial Team / Distributors, to ensure country specific registration activities are understood and appropriately addressed.
  • Maintain with the QA Manager the day-to-day activities of Post Market Surveillance, including, but not limited to:
    • logging customer complaints and adverse events
    • coordinating investigations between complainants and contract manufacturing sites and address initiatives to test, change and improve the products as required.
    • Monitor global regulatory trends and requirements impacting the development and commercialization of products and advise colleagues and external partners to ensure compliance.
    • Evaluating manufacturing and labelling changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations
    • Maintaining awareness of global regulatory legislation and assess its impact on business and product development programs
    • Keep abreast of changes in domestic and international regulations and guidelines and advise key staff of compliance/non-compliance with current international regulations, policies and EC directives.
    • Support the team with CE mark Submissions / Significant Changes and Notified Body interactions.
    • Support the team with the preparation of 510(k) regulatory filings and subsequent FDA correspondence on submissions.
    • Carry out other regulatory related duties as required.


Skills/Experience:
  • Bachelor’s degree in engineering or science with a minimum of 4 years of experience in a medical device company.
  • Regulatory certifications in MDR desirable.
  • A minimum of 4 years of experience in the medical device industry.
  • Thorough understanding and knowledge of ISO 13485 and, ISO 14971, MDD & MDR. Proven track record with the ability to successfully manage projects to deadlines
  • Experience working directly with regulatory agencies
  • Strong ability to manage critical projects as part of an interdisciplinary team
  • Excellent problem solving and communication skills
  • Must be self-motivated, highly organises, and detail-oriented
  • Excellent oral and written communication skills
  • Must be able to work as part of a cross functional team
  • Thrives to work in a fast-paced / entrepreneurial environment

For further information please contact James Cassidy [email protected] or call in confidence 086 0204322