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
Job Tools
Contact Info
Colin Clare
Life Science

+353870608656
[email protected]
Connect with me on
Hot Science Jobs
Process Simulation Technical Engineer
Carlow
Electronic Engineer
Dublin
Quality Engineer
Wexford
Quality Control Technician
Carlow
Senior Manufacting Engineer
Republic of Ireland
Senior QC Associate
Dublin
Senior Quality Engineer
Dublin
Quality Specialist & Deputy RP
Limerick
Maintenance Reliability Engineer
Cork
Manufacturing Technician
Clare
Sr. Associate - Quality for Computer Sys
Cork
Utilities Engineer - Black Utilities
Roscommon
Advanced Technologies R&D Manager
Clare
Product Development Engineer
Dublin
EHS Officer
Dublin
Senior Operations Engineer
Galway
Compliance Specialist
Carlow
R&D Engineer
Galway
Validation Engineer
Athlone
Senior Mechanical Engineer
Dublin
R&D Director
Galway
R&D Engineer
Dublin
NPI Process Engineer
Carlow
Responsible Person (RP)
Republic of Ireland
Senior R&D Manager
Athlone
Maintenance Technician
Carlow
Senior R&D Engineer
Clare
Quality Specialist
Clare
CTO
Galway
Scientist (hybrid)
Meath
R&D Engineer
Galway
Senior Design Engineer
Dublin
R&D Engineer
Galway
Senior Associate Quality Control
Dublin
Electronic Engineer
Dublin
Quality Engineer
Galway
Graduate Manufacturing Technician
Kilkenny
Production Operator
Carlow
Engineering Shift Technician
Dublin
R&D Manager
Connaught
Strategic Automation Lead
Waterford
Business Development Manager (Pharmacy)
Cork
Maintenance Technician
Carlow
Senior Regulatory Affairs Specialist
Clare
Principal Software Engineer
Athlone
Clinical Research Associate
Cork
Notified Body Product Assessor -Active D
Canada
Utilities Engineer
Dublin
Validation & Verification Engineer
Dublin
R&D Manager
Connaught
Project Engineer
Roscommon
Senior Regulatory Affairs Specialist
Athlone
Associate QA Specialist (Shift)
Carlow
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Polymer Development Engineer
Galway
Senior Quality Engineer
Leitrim
Project Manager - R&D
Galway
E&I Turnover Engineer
Carlow
R&D Engineer
Clare
R&D Director
Galway
Senior Technical Transfer Engineer - Hyb
Carlow
Production Operator
Meath
Senior R&D Engineer
Dublin
QA Manager
Canada
Senior Design Assurance Engineer
Clare
Account Manager UK and Ireland
Republic of Ireland
QC Bioanalytical Analyst
Dublin North
R&D Engineer
Dublin
R&D Manager
Athlone
Senior Equipment Design Engineer
Dublin
Clinical Research Associate
Cork
Principal Device Engineer
Dublin
Senior Operations Engineer
Galway
Senior Quality Engineer
Dublin
Principal Engineer - R&D
Galway
Quality Control Technician
Carlow
Principal Engineer
Dublin
Design Assurance Engineer
Clare
Senior Quality Systems Engineer
Galway
Principal Scientist Device and Product P
Dublin
Process Engineer
Cork
MS&T Associate Director
Dublin
NPI Process Engineer
Carlow
Technical Transfer Specialist - Remote
Republic of Ireland
Staff R&D Engineer- Customer Focus
Dublin
Senior Design Assurance Engineer
Galway
Principal R&D Engineer
Galway
Senior R&D Engineer
Dublin
Electronic Engineer
Dublin
Senior R&D Manager/Director
Dublin
Head of R&D
Galway
Manufacturing Biotech Associate 24/7 Shi
Meath
Research Officer
Dublin
Senior R&D Engineer
Galway
Maintenance Technician
Kilkenny
Senior QA Associate (Shift)
Dublin
Senior R&D Engineer
Galway
Electronic Engineer
Dublin
Principal Engineer - R&D
Galway
Senior Process Development Engineer
Galway
Clinical Project Manager
Cork
Quality Engineer
Galway
R&D Engineer
Galway
Quality Specialist
Tipperary
Senior Regulatroy Affairs Specialsit
Galway
Quality Technician
Dublin
QA Engineer
Leitrim
Senior Associate Quality Control
Dublin
Senior Quality Engineer
Leitrim
Project Scheduler
Louth
Operations Engineer
Galway
Medical Secretary
Cork
Project Engineer
Cork
R&D Engineer
Galway
Mechanical Design Engineer
Germany
R&D Engineer
Galway
Senior Design Assurance Engineer
Athlone
R&D Engineer
Galway
R&D Lifecycle Manager
Connaught
Senior Equipment Design Engineer
Dublin
Technical Operations Specialist
Cork
Principal Process Development Engineer
Galway
Project Manager
Louth
Biostatistician
Dublin City Centre
Commisioning and Qualification Engineer
Cork
R&D Engineer
Galway
MS&T Associate Director
Dublin
Regulatory Affairs Specialist
Cork
R&D Manager
Athlone
R&D Director
Galway
QA Manager
Canada
Injection Molding Engineer
North Leinster
Senior Technical Transfer Specialist
Cork
Senior R&D Engineer
Galway
Senior Director Statistics Data and Anal
Cork
Senior Analytical Specialist
Limerick
Quality Engineer
Athlone
Quality Engineer
Athlone
Senior Human Factors Engineer
Dublin
Technical Administrator
Tipperary
Manufacturing Engineer
Galway
R&D Senior Program Manager
Galway
R&D Engineer
Galway
Senior R&D Engineer
Galway
Senior Validation Engineer
Carlow
Product Development Engineer
Dublin
R&D Manager
Connaught
Senior Quality Engineer
Dublin
Manufacturing Engineer
Galway
R&D Manager
Galway
Senior R&D Engineer
Galway
Microbiologist
Cork
Senior R&D Engineer
Dublin
Product Development Engineer II
Athlone
Senior Maintenance Technician
Roscommon
Senior Project Manager - Process Develop
Cork
Lead Maintenance Reliability Engineer
Westmeath
R&D Manager
Galway
Technology Transfer Specialist
Meath
Quality Assurance Specialist (Shift)
Carlow
Senior Quality Engineer-Remote
Republic of Ireland
Product Development Technician II
Galway
Quality Technician
Dublin
R&D Manager
Dublin
Production Operator
Carlow
Manufacturing Technician
Clare
R&D Manager
Galway
R&D Technician
Galway
QA Validation Specialist
Meath
Quality Control Technician
Carlow
Principal Heart Valves Engineer
Galway
R&D Engineer
Galway
Technical Transfer Specialist
Cork
Injection Moulding Engineer
Leitrim
Senior Analytical Scientist
Cork
R&D Manager
Connaught
Senior Recruitment Consultant
Republic of Ireland
Advanced Technologies R&D Manager
Clare
CTO
Dublin
Senior Associate Quality for Computer S
Limerick
Senior Electronics Engineer
Limerick
Senior Recruitment Consultant
Dublin
Manufacturing Technician
Clare
Product Development Engineer
Galway
Process Chemist
Limerick
QC Systems Specialist
Dublin
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Production Operator
Dublin
Senior Process Engineer
Dublin
Project Engineer
Limerick
Senior Manager Bioanalytical QC Lab
Limerick
Senior Regulatory Affairs
Galway
Sales/Customer Service Administrator
Clonmel
QC Separation Analyst
Cork
Production Operator
Dublin
Principal Engineer
Dublin
Injection Molding Engineer
North Leinster
Cleaning Validation Specialist
Cork
Material Handler
Carlow
Quality Engineer
Galway
Principal Engineer
Dublin
Maintenance Reliability Engineer
Tipperary
Project Manager - R&D
Galway
Quality Assurance Engineer
Longford
R&D Engineer
Galway
Principal Engineer - R&D
Galway
R&D Engineer
Galway
Manufacturing Project Engineer
Mayo
Regulatory Affairs Associate
Cork
Quality Systems Specialist
Tipperary
Senior Recruitment Consultant
Republic of Ireland
Clinical Trial Quality Representative
Cork
Technical Life Cycle & Engineering M
Galway
Senior Quality Systems Engineer
Galway
Quality Assurance Specialist (Shift)
Carlow
Senior Microbiologist
Dublin
Senior R&D Manager
Athlone
EHS Specialist
Meath
Senior R&D Engineer
Galway
Injection Moulding Engineer
Athlone
Biomedical Engineer
Dublin
Senior Electronic Engineer
Dublin
Process Development Engineer
Galway
Project Manager Design Assurance
Galway
Principal R&D Engineer
Dublin
R&D Technician II
Galway
R&D Engineer
Galway
Process Safety Specialist
Tipperary
Quality Manager
Wexford
R&D Engineer
Galway
Upstream Manufacturing Process Specialis
Cork
R&D Program Manager
Dublin
Quality Manager
Galway
Senior R&D Engineer
Galway
Facilities Engineer
Carlow
Reliability Engineering Consultant - Rem
Republic of Ireland
R&D Manager
Galway
Quality Engineer
Galway
Senior Design Assurance Engineer
Clare
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 Specialist


Reference:CCL (AHPD-441806) Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Regulatory Affairs

Job Title: Senior Regulatory Affairs
Location: Bishopstown, Cork

Benefits: Competitive Salary, Bonus, Pension, Healthcare + Excellent opportunity to develop your experience and career in an exciting company.

Company:
My client have recently been acquired and have developed a breakthrough single-use medical device, that addresses pain points of the current treatment of the surgical tympanostomy, a procedure that drains out the excess fluid built up in the ear.

Overview:
In this role you will ensure that the company’s products and services comply with all relevant regulations and standards. You will collaborate with cross-functional teams to facilitate the regulatory approval process, manage submissions, and maintain compliance with evolving regulatory requirements. This is an exciting opportunity to be at the forefront of innovation and make a significant contribution to the company's success. This position requires an enthusiastic self-starter with a willingness to be a “hands-on” contributor.

Responsibilities:

  • Develop and execute regulatory strategies for product registration, approval, and compliance.
  • Manage day-to-day regulatory activities as well as handling multiple projects related regulatory compliance enhancements.
  • Management of regulatory submissions, including the preparation, maintenance, review, and submission of regulatory documents and applications to health authorities.
  • Support the team to obtain / retain country-specific regulatory registrations on a global basis.
  • Manage the implementation of MDSAP within the organisation.
  • Monitor and ensure compliance with national and international regulatory requirements and quality standards.
  • Identify and assess potential regulatory risks and propose/implement effective mitigation strategies.
  • Work closely with QA, R&D, Operations, Clinical Affairs, and other departments to integrate regulatory requirements into QMS and product development processes.
  • Stay current with changing regulations, guidelines, and industry trends.
  • Contribute to maintaining the highest level of quality within the organisation by assessing overall risk profiles and then creating programs / tools to mitigate potential risk
  • Maintain the day-to-day activities of Post Market Surveillance, including, but not limited to:
    • Working collaboratively with KARL STORZ
    • 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
    • Regulatory trending and reporting activities as required
    • Manage CE mark submissions, significant change notifications and Notified Body interactions.
    • Support the team with the preparation of international regulatory filing, including 510(k) submissions and subsequent FDA correspondence.
    • Review / approve public-facing materials for regulatory compliance
    • Carry out other regulatory-related duties as required.


Education

  • Bachelor’s degree in Engineering or Science with a minimum of 6 years of regulatory experience in the medical device industry.
  • Regulatory certifications in EU MDR and US FDA desirable.
  • Thorough understanding and knowledge of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, 21 CRF 820 and supporting standards.
  • 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.


Does this sound like your next career move? To apply, forward your application to the link provided or contact me on 087 0608656 OR [email protected]