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
Hot Science Jobs
Biomedical Engineer
Dublin
Senior Quality Engineer
Galway
Electrical and Instrumentation Turnover
Carlow
Cleaning Validation Specialist
Cork
Product Lead
Dublin
Microbiology Manager
Dublin
Process Support Specialist
Carlow
Quality Technician
Dublin
R&D Engineer
Clare
Quality Technician
Dublin
Biostatistician
Dublin City Centre
Commissioning and Qualification Engineer
Cork
Product Development Engineer II
Athlone
Senior Recruitment Consultant
Republic of Ireland
HPLC QC Consultant - Greece
Republic of Ireland
Senior Regulatory Affairs Specialist
Clare
Process Engineer - Water Formulations
Limerick
Chemical Engineer
Tipperary
Senior R&D Engineer
Dublin
Senior QC Associate
Dublin
Product Development Engineer II
Athlone
Project Manager - R&D
Galway
QA Manager
Canada
Senior Operations Engineer
Galway
Quality Engineer
Wexford
R&D Engineer
Galway
Staff R&D Engineer- Customer Focus
Dublin
QA Manager
Canada
Compliance Specialist
Carlow
CMC Regulatory Senior Scientist
Cork
Manufacturing Engineer
Cork
Product Development Engineer
Galway
Senior Design Engineer
Dublin
Senior Mechanical Engineer
Dublin
Qualified Person
Limerick
R&D Engineer
Galway
Injection Moulding Engineer
Athlone
Quality - Tech Transfer Specialist
Cork
Technical Specialist - Process Support
Cork
Senior R&D Manager
Athlone
Operations Specialist
Louth
Senior Quality Engineer-Remote
Republic of Ireland
R&D Engineer
Clare
Senior R&D Engineer
Galway
Suite Team Delivery Lead
Tipperary
Operational Excellence Specialist
Meath
R&D Manager
Galway
Senior Regulatory Affairs Specialist
Athlone
Head of R&D
Galway
Senior Electronic Engineer
Dublin
Recruitment Consultant
Republic of Ireland
Senior Reg Affairs Specialist - Post Mar
Galway
Aseptic Process Lead
Carlow
R&D Director
Galway
Senior Quality Engineer
Dublin
Senior Quality Engineer
Limerick
Manufacturing Technician
Clare
R&D Director
Galway
R&D Manager
Galway
Project Manager - Capital Projects
Meath
Lead Maintenance Reliability Engineer
Westmeath
CQV Lead
Tipperary
Process Validation Engineer
Cork
Senior R&D Manager - Lifecycle Manag
Galway
Process Engineer (NPI)
Carlow
Injection Molding Engineer
North Leinster
Project Engineer
Roscommon
Senior HVAC Engineer
Dublin
Director of Quality Engineering
Limerick
Shift Technician (Injection Moulding)
Kildare
Senior Recruitment Consultant
Republic of Ireland
Manufacturing Technician
Clare
Global Labelling Technical Regulatory Af
Cork
Cleaning Validation Specialist
Carlow
Technical Life Cycle & Engineering M
Galway
Electrical Engineer
Limerick
Regulatory Affairs Specialist
Cork
Senior Project Manager - Process Develop
Cork
Senior Associate Quality Control NPI
Dublin
QA Engineer
Leitrim
Senior R&D Manager - Lifecycle Manag
Galway
Senior Quality Engineer
Dublin
Electrical Engineer
Cork
Upstream Manufacturing Process Specialis
Cork
Senior R&D Engineer
Galway
Manufacturing Project Engineer
Mayo
Associate QA Specialist (Shift)
Carlow
R&D Manager
Connaught
Senior R&D Engineer
Galway
QA Lead DS/DP Manufacturing
Louth
Senior R&D Engineer
Dublin
Senior Design Assurance Engineer
Galway
Clinical Project Statistician
Cork
Electronic Design Engineer
Galway
Notified Body Product Assessor -Active D
Canada
Project Manager - R&D
Galway
Responsible Person (RP)
Republic of Ireland
Project Engineer
Limerick
Microbiologist
Louth
C&Q Lead
Tipperary
Quality Validation Engineer
Limerick
Manufacturing Technician
Clare
Senior Electronics Engineer
Dublin
Compliance Specialist
Carlow
QC Laboratory Technician Shift (Incoming
Carlow
Senior Technical Scientist - Technical T
Cork
R&D Manager
Connaught
Engineering Projects Lead
Carlow
Sr. Associate - Quality for Computer Sys
Limerick
Clinical Project Statistician
Cork
QA Specialist (hybrid)
Cork
Technical Sales Manager (Chemistry)
Westmeath
Senior Project Engineer
Cavan
Technical Transfer Specialist
Cork
Senior Validation Engineer
Cork
Maintenance Reliability Engineer
Tipperary
Senior Process Engineer
Cork
Lead Chemistry Analyst
Cork
R&D Manager
Galway
Senior Quality Control Associate
Dublin South
Cleaning Validation Specialist
Cork
Senior Regulatory Affairs Specialist
Athlone
Senior Quality Engineer
Leitrim
NPI Process Engineer
Carlow
Senior Quality Engineer
Leitrim
Quality Control Technician
Carlow
Aseptic Process Owner Lead
Dublin
Quality Manager / PRRC
Dublin
R&D Engineer
Galway
Injection Molding Engineer
North Leinster
Quality Specialist
Tipperary
Technical Life Cycle & Engineering M
Galway
Senior R&D Engineer
Dublin
Senior Process Engineer
Cork
MES Engineer
Cork
Manufacturing Process Specialist
Cork
CQV Engineer (CIP Start Up)
Denmark
CSV Engineer - IT Labs
Limerick
Quality Systems Specialist
Galway
Principal Software Engineer
Athlone
Sr. Associate - Quality for Computer Sys
Cork
Manufacturing Technician
Clare
Maintenance CMMS Engineer
Tipperary
Senior Electrical Engineer
Galway
Process Development Engineer
Galway
Senior R&D Engineer
Clare
Batch Record Reviewer
Cork
Quality Control Analyst
Greece
Project Engineer
Republic of Ireland
Senior Quality Engineer
Dublin
Senior R&D Engineer-New Product Deve
Westmeath
Associate Global Trade Ops
Dublin
Principal R&D Engineer
Dublin
Senior Electronic Design Engineer
Dublin
R&D Engineer
Galway
Technical Specialist - Manufacturing Pro
Cork
Validation Engineer
Athlone
Senior Regulatory Affairs
Galway
Batch Record Reviewer
Cork
Process Engineer
Cork
Validation & Verification Engineer
Dublin
Senior Equipment Design Engineer
Dublin
R&D Manager
Connaught
Process Engineer
Limerick
Technical Transfer Specialist
Cork
Engineering Business Manager
Dublin
Cleaning Validation Specialist
Cork
Account Manager UK and Ireland
Republic of Ireland
Procurement Senior Specialist
Meath
Senior Regulatory Affairs Specialist
Dublin
Medical Device Director
Republic of Ireland
Sales Executive (Nutritional Supplements
Cork
Cleaning Validation Specialist
Cork
Project Engineer
Tipperary
Senior R&D Engineer
Galway
R&D Manager
Galway
Senior R&D Manager
Athlone
Principal R&D Engineer
Galway
Principal Scientist Global Regulatory Af
Cork
Product Development Engineer II
Athlone
Manufacturing Project Engineer
Sligo
R&D Engineer
Dublin
Clean Utilities Engineer
Cork
Lead Maintenance Reliability Engineer
Westmeath
Senior Associate Scientist (Shift)
Dublin
Bioprocess Material Associate - Shift
Dublin
Senior Operations Engineer
Galway
R&D Engineer
Galway
Manufacturing Engineer
Limerick
Senior Manufacting Engineer
Republic of Ireland
Senior R&D Engineer
Dublin
QC Separation Analyst
Cork
Associate Director Clinical Regulatory S
Cork
R&D Program Manager
Dublin
Principal Scientist Global Regulatory Af
Limerick
Project Manager
Limerick
Biostatistician
Dublin City Centre
Technical Transfer Specialist
Dublin
Qualified Person
Limerick
QC Micro Analyst (Shift)
Cork
Technical Transfer Specialist - Remote
Republic of Ireland
Principal Preclinical Scientist
Galway
Project Manager - R&D
Galway
Injection Molding Engineer
North Leinster
Software Design Assurance Engineer
Dublin
Senior Project Equipment Engineer
Dublin
R&D Director
Galway
Warehouse Operations Specialist
Louth
Validation Engineer
Carlow
Process Simulation Technical Engineer
Carlow
Principal R&D Engineer
Dublin
Senior Regulatroy Affairs Specialsit
Galway
R&D Director
Galway
Business Manager (Pharma Chemicals)
Westmeath
Manufacturing Engineer
Cork
Quality Control Technician
Carlow
Project Enginer
Dublin South
R&D Project Manager
Galway
QA Operations Specialist
Greece
R&D Engineer
Dublin
Quality Engineer
Athlone
Senior Project Engineer - Utilities
Dublin
Consultant




Search Results for Regulatory Affairs Director
Job Title. Location Salary Actions

Global Labelling Technical Regulatory Affairs Lead (Associate Director)

Global Labelling Technical Regulatory Affairs Lead (Associate Director) Our client is a global healthcare leader with employees around the world who work to discover and bring life-changing medicines to those who need them. Their office in Cork consists of a talented diverse team of over 2,000 employees across 60 nationalities who deliver innovative solutions that add value across a variety ofBusiness Service functions including Medical, Clinical Trials, Finance, Information Technology and more. They provide a premium workspace across our ca...

Location: Cork,
Global Labelling Technical Regulatory Affairs Lead (Associate Director) 		Cork Not Disclosed

Senior Director Global Regulatory Lead Early Clinical Development

Senior Director Global Regulatory Lead Early Clinical Development Our client, a global pharma company, are currently recruiting for a Senior Director Global Regulatory Lead Early Clinical Development to joint their team on a permanent basis. As Senior Director Global Regulatory Lead Early Clinical Development you will be the regulatory regional lead for assigned molecules in development. You will be responsible for driving the regulatory strategy for development in the US and Canada from discovery through the start of registration studies. You will partner with other global...

Location: Cork,
Senior Director Global Regulatory Lead Early Clinical Development 		Cork Not Disclosed

Quality and Regulatroy Manager

QUALITY & REGULATORY MANAGER Our client an indigenous Irish medical device company who has recently undergone significant investment are currently seeking a Quality and Regulatory Manager to join their team. Reporting to executive leadership the Quality and Regulatory Manager will have a proven ability to lead the quality assurance agenda across the company, possess knowledge of regulatory processes for EU and FDA product clearance, demonstrate excellent people and team management skills and experience of quality management in the context of R&D and design ...

Location: Galway,
Quality and Regulatroy Manager 		Galway Not Disclosed

Senior 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 Se...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

Senior 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 Se...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

Senior 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 Se...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

Senior Regulatory Affairs Specialist

Job title: Senior Regulatory Affairs Specialist 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 Reg...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

Senior Regulatory Affairs Specialist

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. Rep...

Location: Athlone, Clare, Connaught, Galway, Galway City,
Senior Regulatory Affairs Specialist 		EU Not Disclosed

Senior Reg Affairs Specialist - Post Market

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 t...

Location: Galway, Galway City,
Senior Reg Affairs Specialist - Post Market 		Galway Not Disclosed

Senior Regulatory Affairs Specialist

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 pl...

Location: Clare, Connaught, Galway, Galway City, Limerick,
Senior Regulatory Affairs Specialist 		EU Not Disclosed
Subscribe RSS feed for this search

Regulatory Affairs Director Career Profile

Regulatory Affairs Director


A strategic role which is responsible for the overall direction of the company, often involved in a smaller company at start-up stage. The spec below refers to an example position in the Medical Device sector

Key Responsibilities

  • Compliance with and adherence to medical device regulations in the geographical areas mentioned.
  • Achieve approval for these 2 products to be sold in new territories, in accordance with Class III Medical Device regulations.
  • Introduce and managed design control and quality systems.
  • Regular meetings with other territories, to collaborate on solutions and current progress. Included in this will be frequent air travel.
  • Dealing directly with relevant local regulatory bodies.
  • Managed Customer Complaints though extensive consultation with physicians and Sales and Marketing personnel.
  • Assisting with research and seeking regulatory approval in relation to possible other clinical indications of the products in various markets.
  • Authored and deliver product presentations to physicians and to sales personnel.
  • Liaise with international colleagues in relation to ongoing clinical monitoring.

Skills / Experience

  • B.Sc. degree in Life Sciences, advanced degree preferred.
  • 10+ years experience in Medical Device Regulatory Affairs, specifically dealing with emerging geographical markets. 4 years in a senior management capacity, preferably internationally.
  • Knowledge of GI / urinary diseases.