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
EHS&S Manager
Waterford
Senior CSV Specialist- Hybrid
Republic of Ireland
Quality Engineer
Limerick
Scientific Consultant
Republic of Ireland
VP of R&D
Republic of Ireland
QA Specialist
Dublin
Project Engineer
Limerick
Process Engineer
Republic of Ireland
QC Analyst
Dublin
Project Engineer
Limerick
R&D Manager
Galway
GMP Inspector
Dublin
Quality Specialist
Tipperary
Senior R&D Engineer
Limerick City
EHS Trainer
Dublin
Quality Engineer
Limerick
R&D Engineer
Dublin
Process Engineer
Limerick
Regulatory Affairs Specialist
Republic of Ireland
Project Engineer
Limerick
NPI Manager
Dublin
Engineering Technician
Dublin South
Senior Program Manager
Republic of Ireland
Production Team Lead
Dublin South
R&D Manager
Limerick
R&D Engineer
Galway
Project Engineer
Limerick
Project Manager
Limerick
C&Q Engineer
Dublin
Head of R&D
Galway
QA Contractor
Dublin City Centre
R&D Engineer
Limerick City
QA Manager
Dublin
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

Regulatory Affairs Specialist


Reference:JCAO1208 Location: Cork
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed

Regulatory Affairs Specialist (Remote/Hybrid)



Our client a high potential start up medical device company currently seeks a Regulatory Affairs Specialist to join their team. Reporting to the Clinical and Regulatory Affairs Manager, the Regulatory Specialist will be responsible for helping with compliance to standards, regulatory submissions and annual reporting to the notified body and FDA. The Regulatory Affairs Specialist must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. This position requires an enthusiastic self-starter with a willingness to be a “hands-on” contributor. Excellent organisational skills, ability to balance immediate vs. long term priorities and strong multi-tasking skills are a necessity. An ability to work in a flexible and small entrepreneurial environment is essential and there is an excellent package available for the right candidate.



Role/Responsibilities:

  • Work closely with the QA Manager to ensure the effectiveness of the QMS to regulations
  • Managing day-to-day regulatory activities as well as handling multiple projects related to product and compliance enhancements.
  • Work closely with the QA Manager for notified body audits and other audits as required.
  • Assist in the migration from MDD to MDR within the organisation.
  • Support the wider team to ensuring product manufacture and testing meets the requirements of both CE mark and FDA submissions.
  • Work with the organisation’s suppliers to ensure the products’ process validations and risk management files are to the standard of regulatory submissions.
  • Provide strategic regulatory insight to team members regarding product development plans
  • Work with the Commercial Team / Distributors, to ensure country specific registration activities are understood and appropriately addressed.
  • Maintain with the QA Manager the day-to-day activities of Post Market Surveillance, including, but not limited to:
    • logging customer complaints and adverse events
    • coordinating investigations between complainants and contract manufacturing sites and address initiatives to test, change and improve the products as required.
    • Monitor global regulatory trends and requirements impacting the development and commercialization of products and advise colleagues and external partners to ensure compliance.
    • Evaluating manufacturing and labelling changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations
    • Maintaining awareness of global regulatory legislation and assess its impact on business and product development programs
    • Keep abreast of changes in domestic and international regulations and guidelines and advise key staff of compliance/non-compliance with current international regulations, policies and EC directives.
    • Support the team with CE mark Submissions / Significant Changes and Notified Body interactions.
    • Support the team with the preparation of 510(k) regulatory filings and subsequent FDA correspondence on submissions.
    • Carry out other regulatory related duties as required.


Skills/Experience:
  • Bachelor’s degree in engineering or science with a minimum of 4 years of experience in a medical device company.
  • Regulatory certifications in MDR desirable.
  • A minimum of 4 years of experience in the medical device industry.
  • Thorough understanding and knowledge of ISO 13485 and, ISO 14971, MDD & MDR. Proven track record with the ability to successfully manage projects to deadlines
  • Experience working directly with regulatory agencies
  • Strong ability to manage critical projects as part of an interdisciplinary team
  • Excellent problem solving and communication skills
  • Must be self-motivated, highly organises, and detail-oriented
  • Excellent oral and written communication skills
  • Must be able to work as part of a cross functional team
  • Thrives to work in a fast-paced / entrepreneurial environment

For further information please contact James Cassidy [email protected] or call in confidence 086 0204322