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

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

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
Biomedical Engineer Life Science Senior Operations Engineer Midlands Senior Manufacturing Engineer Quality Assurance Electronic Engineer Validation Scientist QA Validation Specialist Operational Excellence Lead Quality Systems Engineer Research Engineer Design Assurance Regulatory Affairs Consultant Research and Development Scientist NPD Technologist IT Solutions Life Science Junior Product Specialist Equipment Engineer Automation Engineer Programmer Athlone Connected Health Leitrim Consultant (Medical) Kilkenny Research Assistant Hardware Implementation Engineer Controls Engineer Validation Specialist Westmeath R & D Technician Product Specialist Senior Research and Development Scientist Dublin South Business Development Executive Bioprocess Engineer Graduate Project Manager Clinical Project Manager Supplier Quality Engineer Regulatory Affairs Director Maintenance Engineer Product Development Engineer Quality Systems Lead Senior Quality Engineer Process Engineer Software Developer Engineering BD Manager Research and Development Process Development Engineer Clinical Research Supply Chain Connaught Quality Control Supervisor Contract Quality Systems Specialist Engineering Manager Senior Project Manager Upstream Process Senior Project Engineer Project Development Engineer Limerick Regulatory Affairs Executive Quality Engineer Regulatory Affairs Clinical Research Senior Test Engineer Supply Chain Manufacturing Coordinator Academic Quality Assurance Technologist R and D Director Microbiology Engineering Dublin Cavan Pharmaceutical Production Engineer EHS Engineer Louth Biotechnologist Laois Validation Engineer Dublin North Regulatory Affairs Technical Support Biotechnology QA Manager Research and Development Engineer Technical Project Manager Galway Mechanical Engineer Product Manager Technical Specialist Principal Scientist Limerick City Quality Control Manager Biomedical Scientist Leinster R and D Manager Dublin Greater Lead Quality Engineer Dublin City Centre Design Engineer Regulatory Affairs Officer Dublin West Offaly New Product Development Engineer Technical Support Specialist Electrical Engineer Quality Specialist Manufacturing Executive Roscommon Chemistry Kildare Biotechnology Specialist North Leinster Clare Biotechnician Validation Manager Laboratory Project Manager Principal Research Scientist Regulatory Affairs Specialist QA RA Engineer Mayo Regulatory Affairs Manager Biopharmaceutical Quality Manager Healthcare Senior Automation Engineer Process Technician R and D Biochemist Academic QE Manufacturing Engineer Meath Software Engineer Galway City Donegal Project Engineer Snr R and D Engineer Snr Validation Engineer Research Scientist Principal Engineer Republic of Ireland Scientific Medical Device Maintenance Technician Product Development Technologist Longford Contract QA Specialist Manufacturing and Technology Manager Regulatory Affairs Manufacturing Engineer Research and Development Technician QA Engineer Project Lead Medical Affairs Senior Regulatory Affairs Officer C++ Software Engineer Sligo Research Fellow Senior Research and Development Engineer Applications Engineer