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
Project Engineer
Limerick
R&D Manager
Galway
Project Engineer
Limerick
Regulatory Affairs Specialist
Republic of Ireland
Process Engineer
Republic of Ireland
Quality Engineer
Limerick
R&D Manager
Limerick
NPI Manager
Dublin
C&Q Engineer
Dublin
QA Specialist
Dublin
Process Engineer
Limerick
Engineering Technician
Dublin South
QA Manager
Dublin
Head of R&D
Galway
VP of R&D
Republic of Ireland
PHD Chemist
Dublin
Project Engineer
Limerick
R&D Engineer
Limerick City
Quality Consultant/Manager
Republic of Ireland
Person in Charge
Roscommon
Senior R&D Engineer
Limerick City
EHS Specialist
Limerick
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

Director of Regulatory Affairs


Reference:JCAO2621 Location: Galway
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed

Our client a global medical device companywho have established a European Centre of Excellence in Ireland are currently seeking a Director of Regulatory Affairs to join their team. The Director of Reg Affairs will support worldwide regulatory submissions and audits outside of USA. The Director of Regulatory Affairs will report to VP of International Operations and will be a dynamic, detail-oriented, self-directed contributor and will spot opportunities to develop and optimize regulatory strategy while managing multiple projects and priorities. The Director of Regulatory Affairs will be responsible for planning, compliance, and documentation EU MDR, and other applicable country regulations.


Role/Responsibilities:

  • Provide timely notification of document changes (e.g., ISO 13485 Certificate) to the appropriate health authorities.
  • Review and ensure that all product labelling complies with applicable regulatory requirements,
  • Review and ensure that the company website and marketing collateral accurately reflect product descriptions, intended use, and specifications.
  • Lead external audits with regulatory agencies, ensuring findings are documented, and corrective actions are effectively taken.
  • Participate as the regulatory representative on product development teams.
  • Participate in Risk Management and Risk Analysis reviews for all products.
  • Perform duties as the regulatory management representative for company as per domestic and international regulations.
  • Manage regulatory requirements and compliance for all companys locations
  • Lead the team in the maintenance of our Clinical Evaluation Reports.
  • Provide regulatory input into the study setup, including country feasibility and ensuring adherence to local requirements and legislation
  • Ensure all agency correspondence and commitments are appropriately tracked and archived in accordance with companies procedures, or develop new procedures as necessary
  • Collect, share and interpret emerging regulations, ensure alignment with clinical development and strategy
  • Establish a Rapid Response Team as necessary to develop and obtain alignment on strategy for responses to regulatory authorities
  • Exhibit ownership and accountability for projects and internal assignments
  • Perform other work-related duties as requested, directed, or assigned by management.
  • Manage a small team responsible for QA/RA across the organization, including internal Audits.
Skills/Experience
  • Minimum of MSc or equivalent degree is required
  • Advanced degree (PhD, MD or Pharm D) strongly preferred (Regulatory Affairs Certification (RAC) is a plus)
  • Experience working with medical devices (ideally Class III).
  • Experience leading or participating in notified body audits of medical devices.
  • Experience with the ISO 13485 Medical Device Quality System.
  • Knowledge of EU Medical Device Regulatory (MDR) requirements.
  • Knowledge or familiarity with Statistical Process Controls (SPC).
  • Experience in maintaining EU Technical Files for CE marking compliance.
  • Familiarity with FDA Good Manufacturing Practices (GMP).
  • Regulatory Affairs Certification (RAC) by the Regulatory Affairs Professional Society (RAPS) is preferred.
  • Experience managing QA/RA in an Agile Software Development Environment.
  • Ability to work independently, self-directed.
  • Excellent interpersonal, organizational, communication, and presentation skills.
  • Optimistic, positive, can-do attitude and high energy approach.
For further information please contact James Cassidy [email protected] or call in confidence 086-0204322