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
Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
Connect with me on
Quality Engineer
Westmeath
Project Manager
Limerick
R&D Manager
Galway
Project Engineer
Limerick
Project Engineer
Tipperary
Medical Device Director
Republic of Ireland
R&D Engineer
Dublin
C&Q Lead
Tipperary
R&D Manager
Galway
Process Engineer
Limerick
CQV Lead
Tipperary
R&D Manager
Galway
Clinical Evaluator
Republic of Ireland
Recruitment Consultant
Republic of Ireland
R&D Director
Galway
Project Engineer
Republic of Ireland
Responsible Person (RP)
Republic of Ireland
Quality Engieer
Dublin Greater
Quality Specialist
Tipperary
Quality Engineer
Roscommon
Senior Recruitment Consultant
Republic of Ireland
Head of R&D
Galway
Senior R&D Clinical Engineer
Republic of Ireland
R&D Manager
Galway
R&D Director
Galway
Senior Recruitment Consultant
Republic of Ireland
Analytical Chemist
Tipperary
Project Engineer
Limerick
R&D Director
Galway
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Senior Regulatory Affairs Specialist


Reference:JCAO3103 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Our client a medical device start up are looking for a Senior Regulatory Affairs Specialist to support the product development of a cutting-edge device through design development, verification, clinical trials, validation and regulatory approvals. This position can be fully remote.


Role/Responsibilities

  • Provide regulatory guidance to product development team, working closely with cross-functional team members to develop and implement the regulatory strategy.
  • Lead the development, submission and maintenance of high quality clinical and regulatory files to the relevant ethical committees and regulatory agencies, ensuring successful approval.
  • Support the creation and maintenance of product design and technical documentation in compliance with the relevant regulations and standards (Class III, animal derived, implantable devices).
  • Assess and support design and process changes with cross-functional team members, ensuring completion of all associated regulatory activities.
  • Keep up to date with changes in applicable regulatory requirements and standards, and where appropriate coordinate and/or conduct gap assessment activities.
  • Participate in discussions with regulatory authorities.
  • Assist company preparation for inspection by notified body and regulatory authorities.
  • Support implementation and continuous improvement of a robust and fully compliant quality system in accordance with ISO 13485, including risk management.
  • Administrate the processes for the control of product information, including labelling, Instructions For Use (IFU), and user training.
  • Ensure interactions with colleagues/stakeholders fully reflects the company values:
  • One Team: working together to ensure the whole is greater than the sum of the parts
  • Personal Ownership: deliver on commitments
  • Open Communication: Honest open-minded communication
  • Fun: celebrate the successes
  • Continuous Learning: at an individual and company level
  • Solution Orientated: Identify problems but focus your energy on solutions
  • Quality Focused: patient safety comes first
Skills/Experience
  • Bachelor’s or master’s degree in science or related disciplines
  • Minimum of five (5) years of related experience in Regulatory Affairs
  • Experience preparing technical documentation for submission to regulatory agencies
  • Class III medical device experience preferred
  • Clinical trial experience preferred
  • Working knowledge of GMP, FDA QSR and ISO 13485 requirements
  • Excellent communication, organisational and time management skills
  • Availability to travel is required
For further information please contact James Cassidy [email protected] or call in confidence 086 0204322