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

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 Consultant Career Profile

Regulatory Affairs Consultant


Whether it's working in a solo-operation, or in a Regulatory Consultancy, working as a consultant can give flexibility and great challenges to a Regulatory expert with a number of years in industry.

Key Responsibilities

  • Timely preparation and submission variations and renewal applications for National and MRP procedures to the IMB, MHRA and other regulatory authorities.
  • Provide responses to the competent authorities on deficiencies where they arise.
  • Review and update of summary of product characteristics and patient information leaflets as required.
  • Provide guidance and support regarding regulatory requirements as requested by clients.
  • Preparation of clinical trial submissions to various regulatory authorities.
  • Quality Control review of submission documentation prior to relevant competent authorities.
  • Perform internal audits & self-inspections to ISO 9000:2008 standard.
  • Participation in business development/marketing activities.

Skills / Experience

  • Degree minimum in a relevant area.
  • Significant experience in Regulatory setting (CRO / Medical Device / Pharma / Biotech).
  • Team player and client-focussed.
Technical Support Specialist Senior Research and Development Scientist Applications Engineer QE Manufacturing Engineer Research and Development Technician QA Specialist Validation Scientist Quality Systems Specialist Scientific Regulatory Affairs Executive Senior Project Engineer Design Engineer Consultant (Medical) Clinical Trials Advisor Research Scientist Regulatory Affairs Officer Process Development Engineer Athlone Biomedical Scientist Design Assurance Technical Project Manager Cork Junior Product Specialist Process Technician Connected Health Senior Manufacturing Engineer Principal Research Scientist Technical Specialist Leinster QA RA Engineer Validation Specialist Technical Support Academic Research Engineer Pharmaceutical Senior Project Manager Regulatory Affairs Consultant Dublin West Senior Quality Engineer Project Lead Sales Engineer Kildare Project Engineer QA Engineer Electronic Engineer Product Development Engineer Principal Scientist Quality Specialist Snr Validation Engineer Senior Regulatory Affairs Officer Snr R and D Engineer QA Supervisor NPD Technologist Quality Assurance New Product Development Engineer Dublin Biotechnology Quality Control Manager Research Fellow Meath Engineering Regulatory Affairs Academic Senior Scientist Project Development Engineer Mechanical Engineer Medical Affairs Regulatory Affairs Manager Sligo Product Specialist Quality Systems Lead Galway Research and Development Scientist Senior Operations Engineer R and D Director Clinical Research Associate Clare Process Engineer QA Executive Electrical Engineer Quality Systems Engineer Biopharmaceutical Engineering Manager Principal Engineer Validation Coordinator R and D Biochemist Senior Research and Development Engineer Clinical Research Nurse Dublin Greater Regulatory Affairs Specialist Quality Manager Limerick City Clinical Project Manager Manufacturing Engineer Healthcare Laois Quality Control Supervisor Quality Engineer Product Manager BD Manager Dublin South Medical Device QA Validation Specialist Engineering R and D Manager Research and Development Engineer Life Science Regulatory Affairs Director Regulatory Affairs Clinical Research Clinical Research Galway City Product Development Technologist QA Manager Supplier Quality Engineer EHS Engineer North Leinster Biotechnology Specialist Lead Quality Engineer Life Science Dublin City Centre Dublin North Limerick Regulatory Affairs Research and Development Biomedical Engineer R & D Technician Validation Engineer Roscommon Hardware Implementation Engineer Project Manager