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 Quality Engineer
Dublin
R&D Engineer
Galway
Senior Procurement Associate
Limerick
Senior Validation Engineer
Dublin
Procurement Associate
Dublin
CTO
Galway
Senior Operations Engineer
Galway
Project Engineer
Limerick
Maintenance Technician
Carlow
R&D Manager
Connaught
Director of Regulatory Affairs
Galway
R&D Manager
Connaught
Senior Project Manager - Process Develop
Cork
Quality Director
Galway
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
Project Manager
Kildare
Senior Tech Transfer Specialist
Meath
Principal Engineer
Galway
Project Manager
Kildare
Senior Electronic Engineer
Dublin
Senior R&D Engineer
Clare
Product Development Technician II
Galway
Senior Regulatroy Affairs Specialsit
Galway
Design Quality Assurance Engineer
Galway
R&D Engineer
Galway
Sourcing Specialist
Tipperary
Production Operator
Dublin
R&D Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Quality Manager
Galway
Upstream Manufacturing Process Specialis
Cork
Lead Project Engineer
Carlow
R&D Manager
Galway
Senior Quality Engineer
Leitrim
Regulatory Affairs Associate
Cork
Account Manager UK and Ireland
Republic of Ireland
QC Laboratory Technician (shift)
Carlow
Quality Specialist
Clare
Production Operator
Carlow
R&D Manager
Galway
Senior Maintenance Technician
Roscommon
R&D Program Manager
Dublin
R&D Manager
Galway
Design Assurance Program Manager
Galway
R&D Manager
Connaught
Principal Process Equipment Engineer
Dublin South
Manufacturing Engineer
Cork
Project Manager - R&D
Galway
Senior R&D Engineer
Galway
Senior Technical Transfer Engineer - Hyb
Carlow
Reg Affairs Specialist
Clare
R&D Manager
Galway
Advanced Technologies Manager
Galway
Senior Electronic Design Engineer
Dublin
R&D Engineer
Dublin
MS&T Associate Director
Dublin
Principal R&D Engineer
Dublin
R&D Engineer
Galway
Senior R&D Engineer-New Product Deve
Westmeath
Senior R&D Engineer
Galway
R&D Director
Galway
R&D Engineer
Galway
QA Specialist (Hybrid)
Tipperary
Maintenance Technician
Kilkenny
Reliability Engineer
Tipperary
Senior Validation Engineer
Carlow
CAPA Specialist
Cavan
Senior Human Factors Engineer
Dublin
Applications Scientist
Dublin
Senior Manufacting Engineer
Republic of Ireland
Commisioning and Qualification Engineer
Cork
Process Support Specialist
Carlow
Production Operator
Meath
Product Development Manager
Galway
Senior Quality Engineer-Remote
Republic of Ireland
Senior Associate Quality Control NPI
Dublin
Principal Engineer
Galway
Design Quality Assurance Engineer
Galway
R&D Manager
Galway
Senior R&D Engineer
Galway
Product Development Engineer
Dublin
Accreditation Manager
Republic of Ireland
Business Systems Director
Louth
Senior Project Engineer
Cavan
Quality Engineer
Galway
QA Manager
Canada
Injection Moulding Engineer
Athlone
Senior R&D Engineer
Galway
Production Operator
Carlow
R&D Manager
Connaught
Senior R&D Engineer
Galway
Lead Maintenance Reliability Engineer
Westmeath
Product Development Manager
Galway
R&D Technician II
Galway
Senior R&D Engineer
Dublin
Value Stream Team Leader / Production Su
Wexford
R&D Engineer
Galway
Senior Mechanical Engineer
Dublin
Electronic Engineering
Dublin
Laboratory Systems Lead (hybrid)
Meath
Senior R&D Manager - Lifecycle Manag
Galway
Senior R&D Engineer
Galway
Technology Transfer Specialist
Meath
R&D Engineer
Galway
Senior R&D Engineer
Galway
Cleaning Validation Specialist
Cork
Facilities Engineer
Carlow
Quality Specialist
Clare
Clinical Trial Quality Representative
Cork
R&D Engineer
Galway
Quality Engineer
Galway
Manufacturing Project Engineer
Mayo
Project Manager
Louth
Cleaning Validation Specialist
Cork
QA Engineer
Leitrim
Process Chemist
Limerick
Maintenance Reliability Engineer
Tipperary
Validation Engineer
Athlone
Principal Engineer
Dublin
CTO
Dublin
QC Systems Specialist
Dublin
Senior Regulatory Affairs Specialist
Athlone
Cleaning Validation Specialist
Cork
Electronic Engineer
Dublin
Mechanical Engineer
Tipperary
Regulatory Affairs Specialist
Cork
Senior Electronics Engineer
Dublin
Senior R&D Engineer
Galway
R&D Engineer
Galway
R&D Engineer
Galway
Manufacturing Engineer
Galway
Project/Process Engineer - Purification
Cork
VP of Operations
Dublin
R&D Engineer
Galway
Principal Software Engineer
Athlone
Product Development Engineer
Dublin
R&D Engineer
Galway
Principal Device Engineer
Dublin
Biostatistician
Dublin City Centre
Principal Process Development Engineer
Dublin
MS&T Scientist Specialist
Meath
Technical Administrator
Tipperary
Project Manager - R&D
Galway
Senior Quality Engineer
Galway
Project Engineer
Clare
Design Assurance Engineer
Galway
Principal Quality Engineer
Galway
Senior Validation Engineer
Carlow
Senior Regulatory Affairs
Galway
Process Engineer
Carlow
MS&T Bioprocess Engineer
Meath
MS&T Associate Director
Dublin
Quality Engineer
Athlone
Electronic Engineer
Dublin
Senior QC Associate - Cell Culture
Dublin South
Injection Moulding Engineer
Leitrim
Utilities Engineer
Dublin
Senior Regulatory Specialist
Cork
Purchasing & Planning Manager
Wexford
Maintenance Reliability Engineer
Cork
Senior Manufacturing Engineer
Galway
Product Development Technician II
Galway
Validation & Verification Engineer
Dublin
Field Service Engineer (Chromatography e
Westmeath
R&D Engineer
Galway
Senior Microbiologist
Dublin
Manufacturing Engineer
Cork
Quality Systems Manager
Dublin
Senior Process Engineer
Dublin
Electronic Engineer
Dublin
Quality Engineer
Galway
R&D Manager
Dublin
Design Quality Assurance Engineer
Galway
Lead Chemistry Analyst
Cork
Senior R&D Manager/Director
Dublin
Technical Transfer Specialist - Remote
Republic of Ireland
Supply Associate QC - Metrics & Anal
Dublin
Biomedical Engineer
Dublin
Software Design Assurance Engineer
Dublin
Senior R&D Engineer
Clare
Senior Equipment Design Engineer
Dublin
R&D Director
Galway
Maintenance Technician
Carlow
R&D Manager
Galway
R&D Engineer
Galway
Program Manager
Galway
Product Development Engineer II
Athlone
Project Manager
Galway
R&D Manager
Galway
Cleaning Validation Specialist
Carlow
Operational Excellence Specialist
Cork
Senior Human Factors Engineer
Dublin
Senior QC Microbiology
Dublin
Quality Manager
Galway
Senior Design Engineer
Dublin
Quality Engineer
Galway
Advanced Technologies R&D Manager
Clare
R&D Manager
Galway
Principal Engineer
Dublin
Senior Electronic Engineer
Dublin
Medical Writer
Cork
Senior QC 24/7 Shift
Dublin
Principal Process Development Engineer
Galway
Compliance Specialist
Carlow
Responsible Person (RP)
Republic of Ireland
Senior Associate Quality Control
Dublin
Senior Quality Engineer
Leitrim
Senior R&D Engineer
Dublin
Senior Quality Engineer
Leitrim
QA Specialist (REMOTE)
Dublin
R&D Technician II
Galway
R&D Engineer
Dublin
R&D Engineer
Clare
Quality Engineer
Galway
Senior Electrical Engineer
Galway
R&D Manager
Galway
Senior Quality Engineer
Leitrim
Senior Project Manager - Process Develop
Dublin
Senior Quality Engineer
Galway
Notified Body Product Assessor -Active D
Canada
Senior R&D Engineer
Galway
Head of R&D
Galway
Senior Recruitment Consultant
Dublin
Principal R&D Engineer
Dublin
Sales/Customer Service Administrator
Clonmel
Field Sales Manager (Medical Device) - D
Dublin
Quality Engineer
Galway
Product Development Engineer
Dublin
Senior R&D Project Manager
Galway
QA Manager
Canada
R&D Manager
Athlone
Project Manager Design Assurance
Galway
Regional Program Coordinator - Global Le
Dublin
R&D Engineer
Galway
Product Development Engineer II
Athlone
Cleaning Validation Engineer
Carlow
Manufacturing Technician
Clare
Project Engineer
Cork
Quality Engineer
Galway
Senior Design Assurance Engineer
Athlone
Senior Technical Transfer Specialist
Cork
Senior Recruitment Consultant
Republic of Ireland
Mechanical Technician - 2 Cycle
Carlow
R&D Manager
Galway
Senior Design Engineer
Dublin
R&D Director
Galway
Staff Systems Engineer
Limerick
Project Engineer
Cork
R&D Manager
Athlone
Product Development Engineer
Galway
QC Laboratory Technician
Carlow
Laboratory Systems Specialist
Meath
Design Assurance Engineer
Galway
Project Manager Design Assurance
Galway
Manufacturing Engineer
Galway
Principal/Senior R&D Engineer Cathet
Galway
R&D Engineer
Galway
Design Assurance Program Manager
Galway
Investigation Lead
Dublin
Engineering Shift Technician
Dublin
Quality Specialist
Clare
Project Engineer
Roscommon
Quality Specialist
Tipperary
Maintenance CMMS Engineer
Tipperary
Injection Moulding Engineer
Athlone
R&D Technician
Galway
Senior Electronic Engineer
Dublin
Manufacturing Biotech Associate 24/7 Shi
Meath
Senior R&D Engineer
Clare
Quality Specialist
Dublin
Injection Molding Engineer
North Leinster
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]