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
Principal R&D Engineer
Dublin
Head of R&D
Galway
Project Engineer - Senior
Cavan
R&D Engineer
Galway
Reg Affairs Specialist
Connaught
R&D Manager
Galway
Quality Technical Services Manager - 12
Dublin
Senior Engineering Manager
Limerick
Quality Engineer
Athlone
Senior R&D Manager
Athlone
Senior R&D Engineer
Galway
Project Manager - R&D
Galway
Senior Polymer Development Engineer
Galway
R&D Engineer
Galway
Senior Design Assurance Engineer
Galway
Senior Human Factors Engineer
Dublin
Senior R&D Manager/Director
Dublin
Senior R&D Engineer
Dublin
R&D Technician II
Galway
R&D Engineer
Galway
Utilities Engineer
Dublin
MS&T Associate Director
Dublin
Medical Writer
Cork
Injection Molding Engineer
North Leinster
Reliability Engineering Consultant - Rem
Republic of Ireland
Senior R&D Engineer
Galway
Senior Quality Engineer
Leitrim
R&D Manager
Galway
Compliance Specialist
Carlow
Production Operator
Carlow
R&D Engineer
Galway
NPI Process Engineer
Carlow
R&D Director
Galway
Reg Affairs Specialist
Connaught
Principal Preclinical Scientist
Galway
R&D Engineer
Galway
Injection Molding Engineer
North Leinster
Principal Process Development Engineer
Galway
Quality Engineer
Galway
Quality Technician
Dublin
Product Development Engineer
Galway
Lead Chemistry Analyst
Cork
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
QA Manager
Canada
R&D Manager
Connaught
Maintenance CMMS Engineer
Tipperary
Scientist (hybrid)
Meath
Manufacturing Technician
Clare
Product Development Engineer II
Athlone
Project Engineer
Cork
R&D Manager
Athlone
Program Manager
Galway
Principal Process Development Engineer
Dublin
Engineering Business Manager
Dublin
QC Laboratory Technician (shift)
Carlow
Process Support Specialist
Carlow
Senior Manufacturing Engineer
Galway
Design Assurance Program Manager
Galway
Quality Engineer
Galway
Quality Systems Manager
Dublin
Product Development Engineer
Galway
Senior Technical Transfer Specialist
Cork
QC Separation Analyst
Cork
Project Engineer
Cork
Senior R&D Manager - Lifecycle Manag
Galway
Laboratory Systems Lead (hybrid)
Meath
MS&T Bioprocess Engineer
Meath
Mechanical Technician
Carlow
R&D Manager
Connaught
Senior Quality Engineer-Remote
Republic of Ireland
Principal Engineer
Dublin
Technical Transfer Specialist
Cork
Senior Quality Systems Engineer
Galway
Electronic Design Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Operational Excellence Specialist
Cork
Senior Maintenance Technician
Roscommon
Account Manager UK and Ireland
Republic of Ireland
Investigation Lead
Dublin
Validation Engineer
Athlone
Validation Specialist - 50/50 remote
Carlow
Project Manager
Louth
Senior Regulatroy Affairs Specialsit
Galway
Quality Engineer
Galway
Manufacturing Engineer
Galway
Principal Engineer - R&D
Galway
Project Engineer
Limerick
Senior R&D Engineer
Clare
Senior Reg Affairs Specialist - Post Mar
Galway
Responsible Person (RP)
Republic of Ireland
Senior R&D Engineer
Galway
Quality Specialist
Tipperary
MS&T Scientist Specialist
Meath
Process Development Engineer
Galway
R&D Engineer
Galway
Embedded Software Engineer
Dublin
Project Manager Design Assurance
Galway
Regulatory Associate
Cork
Quality Engineer
Galway
Quality Assurance Specialist (Shift)
Carlow
Quality Systems Specialist
Tipperary
Commisioning and Qualification Engineer
Cork
R&D Manager
Connaught
Associate QA Specialist (Shift)
Carlow
Project Manager - R&D
Galway
R&D Engineer
Galway
Project Engineer
Cork
Senior Project Manager - Process Develop
Cork
Production Operator
Carlow
R&D Engineer
Dublin
Design Assurance Engineer
Clare
Quality Engineer
Galway
Process Chemist
Limerick
Applications Scientist
Dublin
Maintenance Technician
Kilkenny
Senior Human Factors Engineer
Dublin
R&D Manager
Galway
Maintenance Technician
Kilkenny
Medical Secretary
Cork
Manufacturing Biotech Associate 24/7 Shi
Meath
Senior QC Associate
Dublin
R&D Manager
Dublin
QA Manager
Canada
Project Manager - R&D
Galway
Regional Program Coordinator - Global Le
Dublin
Project Manager - R&D
Galway
Principal Software Engineer
Athlone
Design Assurance Engineer
Clare
Senior Project Engineer
Cavan
Quality Manager
Galway
Senior R&D Project Manager
Galway
Advanced Technologies Manager
Galway
Chief Medical Officer
Dublin
Regulatory Affairs Associate
Cork
R&D Lifecycle Manager
Connaught
Product Development Engineer
Dublin
Notified Body Product Assessor -Active D
Canada
Director of Regulatory Affairs
Galway
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Director Statistics Data and Anal
Cork
Senior Regulatory Affairs
Galway
Senior R&D Engineer
Galway
Manufacturing Engineer
Galway
Maintenance Technician
Carlow
Quality Specialist
Clare
Operations Engineer
Galway
Principal Scientist Device and Product P
Dublin
Cleaning Validation Specialist
Cork
Production Operator
Dublin
Quality Specialist
Dublin
Staff R&D Engineer- Customer Focus
Dublin
R&D Engineer
Galway
Senior Quality Engineer
Galway
Product Development Engineer
Galway
Lead Project Engineer
Carlow
Design Assurance Program Manager
Galway
Senior Manager Clinical Quality
Cork
QA Operations Specialist (hybrid)
Meath
Senior R&D Manager - Lifecycle Manag
Galway
Electronic Engineering
Dublin
Quality Engineer
Athlone
Senior Mechanical Engineer
Dublin
Senior Operations Engineer
Galway
Electronic Engineer
Dublin
Lead Manufacturing Technician
Kilkenny
R&D Manager
Athlone
R&D Manager
Galway
Senior R&D Engineer
Galway
Biostatistician
Dublin City Centre
Injection Moulding Engineer
Athlone
R&D Engineer
Galway
Senior Quality Engineer
Dublin
Electronic Engineer
Dublin
Electronic Engineer
Dublin
Staff Systems Engineer
Limerick
Senior Recruitment Consultant
Republic of Ireland
Senior Technical Transfer Engineer - Hyb
Carlow
Strategic Automation Lead
Waterford
Senior Design Engineer
Dublin
Safety & Environmental Specialist
Carlow
Quality and Regulatroy Manager
Galway
Manufacturing Technician
Clare
R&D Engineer
Galway
R&D Engineer
Galway
Principal Engineer
Dublin
Quality Manager
Dublin
R&D Senior Program Manager
Galway
Senior R&D Engineer
Galway
Senior Project Manager - Process Develop
Dublin
R&D Engineer
Clare
QA Validation Specialist
Meath
Manufacturing Technician
Clare
Senior Quality Systems Engineer
Galway
Injection Moulding Engineer
Athlone
Design Quality Assurance Engineer
Galway
Quality Engineer
Galway
Director of Quality Engineering
Limerick
Senior R&D Engineer
Dublin
Manufacturing Technician
Clare
Process Simulation Technical Engineer
Carlow
Senior Validation Engineer
Dublin
R&D Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Manufacturing Engineer
Cork
R&D Manager
Galway
Quality Control Technician
Carlow
Senior R&D Engineer
Galway
Cleaning Validation Engineer
Carlow
Senior Equipment Design Engineer
Dublin
EHS Officer
Dublin
Principal/Senior R&D Engineer Cathet
Galway
Material Handler
Carlow
R&D Engineer
Galway
Software Design Assurance Engineer
Dublin
Engineering Shift Technician
Dublin
Senior Process Engineer
Dublin
R&D Director
Galway
Clean Utilities Engineer
Carlow
Quality Systems Specialist
Tipperary
Senior Regulatory Specialist
Cork
Senior Operations Engineer
Galway
QC Laboratory Technician
Carlow
Senior Quality Systems Engineer
Galway
Validation & Verification Engineer
Dublin
Associate Director - Global Core Labelin
Cork
Shift Technician (Injection Moulding)
Kildare
Senior Quality Engineer
Dublin
Product Development Manager
Galway
Senior Quality Engineer
Leitrim
CTO
Dublin
Senior QC Microbiology
Dublin
Project Scheduler
Louth
Senior Process Development Engineer
Galway
R&D Director
Galway
(Senior) Manufacturing Engineers - Globa
Limerick
Principal Engineer - R&D
Galway
Quality Director
Galway
Injection Molding Engineer
North Leinster
R&D Manager
Galway
QA Engineer
Leitrim
DeltaV Lead Automation Engineer
Tipperary
Regulatory Affairs Associate
Cork
Quality Assurance Engineer
Longford
Manufacturing Project Engineer
Sligo
Electronic Engineer
Dublin
Senior Regulatory Affairs Specialist
Westmeath
CTO
Galway
Senior Manufacting Engineer
Republic of Ireland
Reliability Engineer
Tipperary
R&D Engineer
Galway
Electronic Engineer
Dublin
Principal Engineer
Dublin
Quality Engineer
Galway
R&D Manager
Connaught
R&D Engineer
Galway
Product Development Manager
Galway
Consultant




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

Associate Director - Global Core Labeling (Regulatory Affairs)

Associate Director - Global Core Labeling (Regulatory Affairs) 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. They are seeking a Global Labelling Lead who shall be at Associate Director level to join a growing team of Regulatory professionals within their Global Business Centre.The purpose of the Associate Director, Global Regulatory Affairs (GRA) Global Core Labeling role is to lead the development and maintenance of global labeling, including all core labelin...

Location: Cork,
Associate Director - Global Core Labeling (Regulatory Affairs) 		Cork 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

Quality Manager - NPI

Role: Quality Manager - NPI Based in Dun Laoghaire – on site role Benefits: Competitive salary, Healthcare, bonus or share options and Pension contribution, excellent opportunity to expand your career in exciting Medical Device company growing from strength to strength. Company: My client have deep expertise and advanced technologies to continuously innovate their pen needles, insulin syringes and other products. Job Purpose: To provide support for ISO9000/ISO13485 Quality System. Responsible for ensuring adherence to al...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Manager - NPI 		EU Not Disclosed
Subscribe RSS feed for this search

Regulatory Affairs Manager Career Profile

Regulatory Affairs Manager


This role is normally suited to someone with a minimum of 5 years in a Regulatory setting, ideally more. Management, departmental budgeting, training are some of the keys tasks involved on the non-technical side of the role.

Key Responsibilities

  • Coordinating, compiling and submitting Marketing Authorisation variations for existing approvals
  • Composing and reviewing Pre-IND information packages and NDA packages for registration of prescription products in the US through the FDA
  • Liaise with partner companies as the primary Regulatory Affairs contact for the company to achieve product registration in all new worldwide regions within projected timeframes
  • Regulatory Affairs European project team leader for all new projects
  • Interpreting EU and US regulatory guidelines and procedures and ensuring the regulatory compliance of the company in all new regions Establish and analyse department budget
  • Identify and recommend areas for cost savings from and Regulatory and compliance perspective
  • Provide Regulatory advice and feedback for all internal company departments and external partners
  • Maintain and apply a high level of awareness and understanding of the impact of existing and future planned regulations