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
Design Quality Engineer
Galway
Quality System & Regulatory Affairs
Galway
Quality Assurance (QA) Associate
Kildare
R&D Engineer
Galway
Senior Research & Development Engine
Limerick
Quality Assurance Engineer
Longford
Process Chemist
Limerick
Quality Engineer - Supplier
Galway
Senior Engineering Manager
Galway
Business Manager (Woundcare, Orthopaedic
Dublin
Senior Quality Engineer
Dublin
R&D Engineer
Galway
R&D Manager
Galway
Senior Clinical Engagement Project Manag
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Biomedical Engineer
Dublin
R&D Manager
Galway
Senior Regulatory Affairs
Galway
Product Development Engineer II
Athlone
R&D Engineer
Galway
Staff R&D Engineer
Limerick
Senior QC Microbiology
Dublin
Senior Quality Engineer
Dublin
Senior Maintenance Technician
Kilkenny
Senior Project Engineer - R&D
Galway
R&D Manager
Connaught
Senior R&D Engineer
Galway
Lead MSAT Validation Consultant
Republic of Ireland
Senior Quality Engineer
Leitrim
Sales Specialist (Life Sciences)
Dublin
Principal Engineer
Dublin
Principal Software Engineer
Athlone
Quality Assurance Specialist - Tech Tran
Dublin
Principal R&D Engineer
Galway
A.I Specialist
Clare
Project Engineer - Senior
Cavan
Senior Quality Assurance Associate
Dublin
Product Development Manager
Galway
Quality Manager - NPI
Dublin
Senior Manufacting Engineer
Republic of Ireland
Senior Sterile Drug Product MSAT Consult
Republic of Ireland
Documentation Specialist
Louth
Head of Sector (Healthcare)
Dublin
EHS Specialist II
Limerick
Quality Manager - Medical Devices
Limerick City
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior Quality Control Associate
Dublin South
Quality Assurance Specialist
Waterford
Project Engineer
Cork
R&D Director
Galway
Senior R&D Engineer
Galway
CTO
Dublin
Principal Engineer
Dublin
Senior Quality Engineer
Dublin
Product Development Engineer II
Athlone
Quality Assurance Specialist/Manager
Dublin
Manufacturing Technician
Galway
Senior Design Assurance Engineer
Galway
Warehouse Operator
Dublin
Design Assurance Engineer
Galway
Senior Quality Assurance Engineer
Galway
R&D Manager
Dublin
Senior Product Development Engineer
Galway
Responsible Person (RP)
Republic of Ireland
Quality Manager
Dublin
R&D Director
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Product Development Engineer
Galway
Quality Manager
Galway
Senior Equipment Design Engineer
Dublin
Senior Design Assurance Engineer
Galway
Project Manager - New Product Introducti
Dublin
QA Manager
Canada
Senior Product Development Engineer
Galway
R&D Manager
Connaught
Electrical Condition Monitoring Technici
Limerick
R&D Engineer
Galway
Embedded Software Engineer
Dublin
Senior Mechanical Engineer
Dublin
R&D Engineer
Galway
Project Manager
Kildare
Product Development Engineer
Galway
Senior Quality Engineer
Dublin
Application Software Engineer
Galway
Senior QC Analyst
Republic of Ireland
Supplier Quality Engineer
Galway
R&D Program Manager
Dublin
Process Engineer
Galway
Senior R&D Engineer
Dublin
Process Development - Senior Project Man
Dublin
R&D Engineer
Dublin
Senior Process Development Engineer
Dublin
QA Engineer
Leitrim
Quality Specialist
Clare
Laboratory Systems Specialist
Meath
Process Engineer
Leitrim
Senior Product Development Manager
Galway
Senior R&D Engineer
Dublin
R&D Manager
Connaught
Utilities Engineer
Dublin
Quality Engineer - Supplier
Galway
Senior Design Assurance Engineer
Galway
Senior Director of Manufacturing and Sup
Galway
Senior QC Specialist - Equipment & I
Dublin
R&D Engineer
Galway
Quality Technician
Dublin
Senior Quality Assurance Engineer
Galway
Clinical Trial Protocol Specialist
Galway
Quality Manager
Galway
Senior Quality Assurance Specialist
Cork
R&D Engineer
Dublin
Senior QC Microbiology
Dublin
Graduate Occupational Hygiene Consultant
Kildare
LIMS Specialist
Tipperary
Senior Quality Engineer
Galway
Principal Engineer
Dublin
Quality Manager
Galway
Manufacturing Technician
Clare
Quality Assurance Specialist (hybrid)
Dublin
Black Utilities Engineer
Westmeath
Senior Project Engineer
Cork
Senior Microbiologist
Dublin
QC Microbiology Technician
Kildare
EHSS Specialist (Construction & Comm
Athlone
Principal Design and Development Enginee
Galway
Project Manager (hybrid)
Dublin
Key Account Manager - Retail UK National
South East
Clinical Trial Protocol Specialist
Galway
Regulatory Affairs Specialist
Cork
R&D Lifecycle Manager
Connaught
Senior Supply Chain Manager - Supplier E
Dublin
Operations Engineer
Galway
Senior QC Associate - NPI
Dublin
Product Development Technician II
Galway
Principal R&D Engineer
Galway
Quality Assurance Specialist (Hybrid)
Dublin
Sr Principal R&D Engineer
Galway
Regulatory Affairs Manager - Senior
Galway
R&D Manager
Galway
Senior Quality Systems Engineer
Galway
Senior Project Manager - Contract Develo
Dublin
Validation Engineer
Athlone
Senior Clinical Data Analyst
Dublin
Quality Assurance Senior Specialist
Louth
Production Operator
Meath
Website Audit Specialist
Dublin
R&D Manager
Galway
Engineering Shift Technician
Dublin
R&D Technician II
Galway
Injection Moulding Engineer
Athlone
Injection Moulding Engineer
Leitrim
NPI Engineer - Hybrid
Dublin
Analytical Chemist
Tipperary
Senior Client Side Design Manager
Westmeath
Project Manager
Galway
CTO
Galway
Senior Process Engineer
Longford
R&D Manager
Athlone
R&D Director
Galway
Injection Moulding Engineer
Athlone
Reg Affairs Specialist
Connaught
Production Manager
Wexford
Senior Electronics Engineer
Limerick
Senior Maintenance Technician
Roscommon
Documentation Specialist
Louth
Senior Quality Engineer
Leitrim
Senior Research and Development Engineer
Galway
CQV Engineer
Roscommon
Senior Electronic Engineer
Dublin
R&D Engineer
Galway
Senior Quality Engineer
Galway
R&D Manager
Athlone
Quality Specialist
Tipperary
Head of Data Partnerships & Operatio
Dublin
Quality Technician
Dublin
Senior Project Engineer
Cavan
R&D Engineer
Galway
R&D Manager
Connaught
Business Resilience Specialist
Dublin
EHSS Specialist
Athlone
Laboratory Technician (Microbiology &
Dublin
Senior Process Engineer - DP or DS
Dublin
Director of R&D
Limerick
Clinical Advisor - Wound care (Part-time
Dublin
Clinical Trial Protocol Specialist
Galway
Senior Quality Engineer
Galway
Senior Commissioning & Qualification
Roscommon
Quality Assurance Specialist (shift)
Carlow
Business Development Manager
Republic of Ireland
Senior Quality Assurance Technical Suppo
Dublin
Product Development Engineer
Galway
Quality Manager
Galway
Senior Equipment Engineer
Dublin
Senior QC Microbiology
Dublin
Product Development Technician II
Galway
Senior Regulatroy Affairs Specialsit
Galway
Quality Technician
Galway
Senior Electronics Engineer
Dublin
EAP Program Manager
Republic of Ireland
Advanced Technologies R&D Manager
Clare
Senior Operations Engineer
Galway
Director of R&D
Galway
Senior QC Specialist
Dublin
Calibration Technician
Republic of Ireland
Documentation Specialist
Louth
Clinical Sales Specialist (Histology)
Dublin
Design Assurance Engineer
Galway
Documentation Specialist
Louth
R&D Engineer
Galway
Senior Human Factors Engineer
Galway
Business Development Manager (Hospitals)
Cork
Project Manager
Kildare
Quality Control Analyst (Cell Culture)
Carlow
Process Engineer - Sterile Drug Product
Waterford
Quality Engineer
Athlone
QA Deviations Specialist
Dublin
Electronic Engineering
Dublin
Senior Design Assurance Engineer
Galway
Quality Assurance Team Lead
Cork
Manufacturing Technician
Clare
Senior Electrical Engineer
Galway
Senior Quality Assurance Specialist (hyb
Dublin
Design Assurance Engineer
Galway
Senior Regulatory Affairs Specialist
Dublin
R&D Engineer
Galway
Quality Assurance Specialist (Logistics)
Dublin
Process Development Engineer
Galway
R&D Director
Galway
Senior Clinical Data Analyst
Dublin
Senior Design Assurance Engineer
Galway
Principal R&D Engineer
Galway
Project Engineer
Clare
Advanced Technologies R&D Manager
Clare
Quality Systems Manager
Dublin
Senior Quality Engineer
Leitrim
Scientific Officer- Virology
Dublin
Senior NPI Engineer - Hybrid
Dublin
Quality and Regulatory Affairs Manager
Dublin
Principal Design Assurance Engineer
Galway
Sr Electrical Engineer
Galway
R&D Engineer
Clare
Senior Specialist MS&T
Dublin
R&D Manager
Galway
Consultant




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

Quality and Regulatory Affairs Manager

Quality & Regulatory Affairs Manager Location: Dublin, Ireland (Hybrid) Type: Full-Time About the Opportunity An innovative and rapidly growing medical device company is seeking an experienced Quality & Regulatory Affairs Manager to lead quality and regulatory activities as the organisation progresses through post-market clinical activities and prepares for commercial expansion in the United States and Europe. This is an exciting opportunity to join a high-growth MedTech business that has achieved FDA clearance for its first technology indication and i...

Location: Dublin,
Quality and Regulatory Affairs Manager 		Dublin Not Disclosed

Quality Manager

Title: QA / RA Manager Location: ATU Ihub, Dublin Road, Galway Company: My client are a Medical are an early-stage start-up focused on developing patient solutions in the area of palliative care. Their initial technology platform is a catheter-based device used to treat the build-up of fluid in the body. Role: QARA Manager with DA focus on a 9-month contract basis who will thrive in a multidisciplinary start-up environment. Looking for people that are curious, have a similar strong work ethic to our own, and are motivated by the positive influe...

Location: Galway, Galway City,
Quality Manager 		Galway Not Disclosed

Quality Manager

Title: QA / RA Manager Location: ATU Ihub, Dublin Road, Galway Company: My client are a Medical are an early-stage start-up focused on developing patient solutions in the area of palliative care. Their initial technology platform is a catheter-based device used to treat the build-up of fluid in the body. Role: QARA Manager with DA focus on a 9-month contract basis who will thrive in a multidisciplinary start-up environment. Looking for people that are curious, have a similar strong work ethic to our own, and are motivated by the positive influe...

Location: Galway, Galway City,
Quality Manager 		Galway Not Disclosed

Quality Manager

Title: QA / RA Manager Location: ATU Ihub, Dublin Road, Galway Company: My client are a Medical are an early-stage start-up focused on developing patient solutions in the area of palliative care. Their initial technology platform is a catheter-based device used to treat the build-up of fluid in the body. Role: QARA Manager with DA focus on a 9-month contract basis who will thrive in a multidisciplinary start-up environment. Looking for people that are curious, have a similar strong work ethic to our own, and are motivated by the positive influe...

Location: Galway, Galway City,
Quality Manager 		Galway Not Disclosed

Regulatory Affairs Manager- Remote

JOB DESCRIPTION Regulatory Affairs Manager – Medical Devices Location: Ireland (Remote) Reports To: CEO / Founder Employment: Full-time, Permanent Start Date: ASAP About the Company The company is a vertically integrated manufacturer of precision medical device components with international operations. It designs, machines, coats, and packages high-specification titanium components for the global medical device market. The organisation is building its regulatory function from the ground up. This is a foundational hire where you will own the ...

Location: Republic of Ireland,
Regulatory Affairs Manager- Remote 		Republic of Ireland Not Disclosed

Director of Regulatory Affairs

Director of Regulatory Affairs 📍 Galway, Ireland (Hybrid) Lead Regulatory Strategy in a High-Growth MedTech Environment An innovative, growth-stage medical device company based in Galway is seeking an experienced Director of Regulatory Affairs to lead global regulatory strategy and compliance activities. This is a senior leadership opportunity within a dynamic SME environment, offering the chance to shape regulatory direction while partnering closely with executive leadership and cross-functional teams. The Opportunity Reporting to the executive team%...

Location: Galway,
Director of Regulatory Affairs 		Galway Not Disclosed

Senior Regulatory Affairs Manager

Job title: Sr Regulatory Affairs Manager Location: Mervue, Galway Benefits: Top salary, bonus, pension, healthcare and car allowance Overview: As the Senior Manager of Regulatory Affairs, you play a key leadership role within the Acute Care & Monitoring (ACM) operating unit, supporting regulatory activities for a portfolio of products. This role entails implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results ...

Location: Galway, Galway City,
Senior Regulatory Affairs Manager 		Galway Not Disclosed

Regulatory Affairs Manager - Senior

Job title: Sr Regulatory Affairs Manager Location: Mervue, Galway Benefits: Top salary, bonus, pension, healthcare and car allowance Overview: As the Senior Manager of Regulatory Affairs, you play a key leadership role within the Acute Care & Monitoring (ACM) operating unit, supporting regulatory activities for a portfolio of products. This role entails implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes, and ensuring your team delivers high-quality results...

Location: Galway, Galway City,
Regulatory Affairs Manager - Senior 		Galway Not Disclosed

Regulatory Affairs Maanger

Regulatory Affairs Manager Our client a fast-growing medical device company based in the West of Ireland, dedicated to transforming outcomes for patients are seeking a highly motivated Regulatory Affairs Manager to lead and oversee all regulatory compliance activities. This critical leadership role will define and execute regulatory strategies in support of both new product development and post-market activities. Role/Responsibilities Lead the regulatory strategy for new product introductions and support existing products through their full lifecycle. Mana...

Location: Galway,
Regulatory Affairs Maanger 		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

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