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
Senior Manufacting Engineer
Republic of Ireland
Electronic Engineer
Dublin
Production Operator
Carlow
Senior Quality Engineer
Leitrim
R&D Engineer
Dublin
Senior Research and Development Engineer
Galway
Process Development Engineer
Galway
R&D Manager
Athlone
R&D Technician
Galway
Senior Maintenance Technician
Roscommon
Product Development Manager
Galway
Project Manager - R&D
Galway
Engineering Projects Lead
Carlow
Senior Technical Transfer Specialist
Cork
Injection Moulding Engineer
Athlone
R&D Manager
Galway
MS&T Scientist Specialist
Meath
Program Manager
Galway
Electronic Engineer
Dublin
Design Assurance Engineer
Galway
Senior QC Microbiology
Dublin
Senior R&D Engineer
Galway
Shift Technician (Injection Moulding)
Kildare
Quality Engineer
Galway
Manufacturing Technician
Clare
R&D Manager
Connaught
Senior Quality Engineer
Galway
Business Systems Director
Louth
Project Engineer - Senior
Cavan
Production Operator
Carlow
Program Manager
Galway
Quality Engineer
Galway
Senior Equipment Design Engineer
Dublin
QC Separation Analyst
Cork
R&D Manager
Galway
Product Development Engineer
Dublin
Senior R&D Engineer
Galway
R&D Manager
Galway
Production Operator
Dublin
Principal Quality Engineer
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Quality and Regulatroy Manager
Galway
R&D Manager
Galway
Senior Validation Engineer
Carlow
Quality Engineer
Athlone
Program Manager
Galway
Quality Engineer
Athlone
R&D Engineer
Clare
Product Development Engineer
Dublin
Strategic Automation Lead
Waterford
Regional Program Coordinator - Global Le
Dublin
Account Manager UK and Ireland
Republic of Ireland
Production Operator
Dublin
Electronic Engineer
Dublin
Senior Technical Transfer Engineer - Hyb
Carlow
Senior Regulatory Affairs Specialist
Clare
Associate Director - Global Core Labelin
Cork
Quality Control NPI Senior Associate
Dublin South
Technical Life Cycle & Engineering M
Galway
Production Operator
Carlow
Process Simulation Technical Engineer
Carlow
Design Quality Assurance Engineer
Galway
Senior Manufacturing Engineer
Galway
R&D Engineer
Galway
Quality Specialist
Clare
Clinical Trial Quality Representative
Cork
Senior R&D Engineer
Dublin
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
Design Assurance Engineer
Galway
Project Manager - R&D
Galway
Production Operator
Meath
Senior Operations Engineer
Galway
Validation Engineer
Athlone
Design Assurance Engineer
Galway
R&D Engineer
Galway
Senior Tech Transfer Specialist
Meath
Software Design Assurance Engineer
Dublin
R&D Director
Galway
Quality Director
Galway
Senior Regulatroy Affairs Specialsit
Galway
R&D Engineer
Galway
Process Support Specialist
Carlow
R&D Manager
Dublin
R&D Engineer
Galway
Senior Associate Quality Control NPI
Dublin
R&D Manager
Connaught
R&D Manager
Connaught
Regulatory Affairs Associate
Cork
Product Development Engineer II
Athlone
Manufacturing Project Engineer
Mayo
Quality Engineer
Galway
Compliance Specialist
Carlow
R&D Manager
Galway
Product Development Engineer
Dublin
Material Handler
Carlow
Senior Associate Quality Control
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Staff Systems Engineer
Limerick
Quality Manager - NPI
Dublin
Associate QA Specialist (Shift)
Carlow
Production Manager
Dublin
Product Development Engineer
Dublin
Chief Medical Officer
Dublin
Senior Manufacturing Manager
Dublin
R&D Engineer
Galway
Qualified Person (Hybrid)
Meath
Senior Electronic Engineer
Dublin
Staff R&D Engineer- Customer Focus
Dublin
Manufacturing Engineer
Galway
Product Development Manager
Galway
QA Engineer
Leitrim
Senior Design Assurance Engineer
Galway
NPI Process Engineer
Carlow
Maintenance Reliability Engineer
Cork
Principal Process Development Engineer
Galway
Principal R&D Engineer
Dublin
Embedded Software Engineer
Dublin
Senior Human Factors Engineer
Dublin
Quality Engineer
Galway
Senior R&D Engineer
Clare
Electronic Engineer
Dublin
Senior R&D Engineer
Galway
R&D Engineer
Galway
Project Manager Design Assurance
Galway
Senior Design Assurance Engineer
Galway
R&D Engineer
Galway
R&D Technician II
Galway
Senior R&D Engineer
Galway
R&D Engineer
Galway
Cleaning Validation Specialist
Cork
CTO
Galway
Project Manager - R&D
Galway
Project/Process Engineer - Purification
Cork
Head of R&D
Galway
Lead Project Engineer
Carlow
Quality Assurance Engineer
Longford
Project Scheduler
Louth
Senior R&D Engineer
Galway
R&D Engineer
Dublin
Injection Molding Engineer
North Leinster
Maintenance Reliability Engineer
Tipperary
R&D Engineer
Galway
R&D Director
Galway
Design Quality Assurance Engineer
Galway
Director of Quality Engineering
Limerick
R&D Engineer
Galway
Engineering Business Manager
Dublin
Manufacturing Biotech Associate 24/7 Shi
Meath
CTO
Dublin
Quality Manager
Galway
Senior Quality Engineer
Leitrim
Accreditation Manager
Republic of Ireland
Lead Manufacturing Technician
Kilkenny
Project Manager
Kildare
Electronic Engineer
Dublin
Production Operator
Meath
Quality Technician
Dublin
Senior Recruitment Consultant
Republic of Ireland
(Senior) Manufacturing Engineers - Globa
Limerick
Maintenance Technician
Kilkenny
R&D Manager
Galway
Quality Engineer
Galway
Advanced Technologies Manager
Galway
Senior R&D Engineer
Clare
Utilities Engineer
Dublin
Quality Specialist
Tipperary
Principal Engineer
Dublin
Injection Moulding Engineer
Athlone
Principal R&D Engineer
Galway
Senior R&D Engineer
Dublin
Lead Manufacturing Technician
Kilkenny
Senior Regulatory Specialist
Cork
Laboratory Systems Lead (hybrid)
Meath
Principal Engineer
Galway
Senior Regulatory Affairs Specialist
Westmeath
Regulatory Affairs Specialist
Cork
Notified Body Product Assessor -Active D
Canada
Injection Moulding Engineer
Athlone
Senior R&D Manager - Lifecycle Manag
Galway
R&D Manager
Connaught
R&D Manager
Galway
Quality Manager
Dublin
Design Assurance Program Manager
Galway
Senior Electrical Engineer
Galway
Project Engineer
Clare
Reg Affairs Specialist
Connaught
Mechanical Design Engineer
Germany
R&D Manager
Galway
R&D Director
Galway
Senior Quality Engineer
Dublin
Biostatistician
Dublin City Centre
Senior Quality Systems Engineer
Galway
Senior R&D Engineer
Galway
R&D Engineer
Galway
Injection Molding Engineer
North Leinster
Senior R&D Engineer
Galway
Principal Engineer
Galway
Manufacturing Technician
Clare
Technology Transfer Specialist
Meath
Regulatory Affairs Associate
Cork
Mechanical Technician
Carlow
Project Scheduler
Louth
Principal Scientist/Engineer Medical Dev
Dublin
Investigation Lead
Dublin
Senior Design Engineer
Dublin
QA Manager
Canada
MS&T Associate Director
Dublin
Senior QC 24/7 Shift
Dublin
R&D Engineer
Galway
Quality Engineer
Galway
Program Manager
Galway
Project Manager - R&D
Galway
Project Engineer
Limerick
Product Development Engineer
Galway
R&D Engineer
Galway
Senior Mechanical Engineer
Dublin
Senior Recruitment Consultant
Republic of Ireland
Responsible Person (RP)
Republic of Ireland
Senior Project Manager - Process Develop
Dublin
Electronic Design Engineer
Galway
Senior Electronics Engineer
Limerick
Senior Equipment Design Engineer
Dublin
Principal R&D Engineer
Dublin
R&D Engineer
Galway
Applications Scientist
Dublin
Quality Technical Services Manager - 12
Dublin
R&D Engineer
Galway
Quality Engineer
Athlone
Senior Process Development Engineer
Galway
Senior R&D Manager
Athlone
Senior Equipment Engineer
Dublin
Senior Human Factors Engineer
Dublin
R&D Manager
Athlone
Senior QC Associate - Cell Culture
Dublin South
Program Manager
Galway
Manufacturing Project Engineer
Sligo
CAPA Specialist
Cavan
Cleaning Validation Specialist
Carlow
Senior Engineering Manager
Limerick
Senior Electronic Design Engineer
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
Value Stream Team Leader / Production Su
Wexford
Maintenance Technician
Carlow
R&D Technician II
Galway
R&D Director
Galway
Lead Chemistry Analyst
Cork
Product Development Technician II
Galway
E&I Turnover Engineer
Carlow
Process Chemist
Limerick
Senior Equipment Design Engineer
Dublin
Senior Associate Quality Control
Dublin
NPI Process Engineer
Carlow
Senior Regulatory Affairs Specialist
Dublin
Principal Engineer
Dublin
Maintenance Technician
Kilkenny
Project Manager
Kildare
Principal Process Equipment Engineer
Dublin South
Regulatory Associate
Cork
QA Manager
Canada
Injection Molding Engineer
North Leinster
Senior R&D Engineer
Dublin
R&D Engineer
Galway
Senior Quality Engineer
Leitrim
Quality Systems Manager
Dublin
Upstream Manufacturing Process Specialis
Cork
Biomedical Engineer
Dublin
Design Assurance Program Manager
Galway
R&D Manager
Galway
Quality Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
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]