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
Sinead Cullen
Life Science

01 507 9252
[email protected]
Connect with me on
Head of R&D
Galway
QC Scientist
Limerick
Clinical Research Associate (CRA)
Republic of Ireland
Quality Engineer
Limerick
Field Application Scientist
Republic of Ireland
R&D Manager
Galway
Validation Lead
Limerick
Project Engineer
Limerick
Process Engineer
Limerick
Technical Writer
Limerick
Project Engineer
Limerick
Project Manager
Limerick
Quality Engineer
Limerick
Process Engineer
Dublin North
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

Quality and Regulatory Manager


Reference:SCAADN-264287s Location: Dublin
Republic of Ireland
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Quality & Regulatory Affairs Manager
Our client, a leading healthcare organisation are currently recruiting for a Quality and Regulatory Affairs Manager to join their team on a permanent basis. As Quality & Regulatory Affairs Manager you will be responsible for leading the regulatory affairs and quality assurance functions within the organisation. You will manage the department effectively to ensure compliance, continuous improvement and to ensure product quality and customer satisfaction.


Responsibilities

  • Provide Quality & Regulatory strategic direction, training and support to the organisation
  • Ensure business activities are conducted in compliance with the regulations and standards applicable to the business and product range
  • Lead the Quality Management Systems including Documentation, Complaints Management, CAPA and Management Review
  • Responsible for the overall development, implementation, and maintenance of the organisation’s Quality Management System (QMS) for all of its product classifications; medicinal, medical device, cosmetic, food supplement products
  • Ensure Quality System processes are lean, compliant, user-friendly and are well understood throughout the organisation
  • In collaboration with the Management Team, drive continuous improvement and best practices
  • Interact with regulatory agencies, industry organizations, consultants, suppliers, legal counsel and health care professionals
  • Responsible for ensuring adherence to all external regulatory requirements – MDR 2017/745 and 21 CFR 820
  • Manage internal and external audits
  • Maintain and follow up CAPAs
  • Responsible for the implementation of Quality Agreements with partners
  • Enhance a compliance culture throughout the organisation
  • Maintain an ISO13485 Quality System incorporating the company’s existing medicinal QMS
  • Prepare and maintain documentation in compliance with the appropriate regulatory requirements
  • Act as our Responsible Person for Medicinal Products under the company’s Wholesale Distribution Licence (WDA)
  • Work to act our as RPI for medicinal products in the UK and Northern Ireland
  • Adapt existing procedures and documents that best meet the requirements of QS and the workflow within the Company. Create new Standard Operating Procedures, as required
  • Carry out training and communication activities with staff to ensure adequate understanding of Quality Systems and Regulatory requirements
  • Interact with Regulatory Bodies to provide information on requirements for Certifications and approvals
  • Provide Quality and Regulatory inputs into Clinical studies
  • Oversee the Company complaints procedures and ensure that Complaints are managed appropriately across the business
  • Provide technical leadership and vision through the interpretation of new and emerging international regulatory trends pertinent to local business needs and develop and implement strategies and projects to optimize regulatory performance
  • Responsible for final sign-off on all product labels & package inserts for products
  • Provide regulatory advice and perform regulatory assessments of business development opportunities
  • Work through the Brexit requirements for our business across the different classes of product

Requirements
  • Third level qualification in Quality & Regulatory Affairs. An additional qualification in Life Sciences is desirable
  • At least 8 years post-graduation experience in Quality & Regulatory environment with at least 5 years at a similar level
  • Experience in management of Quality Systems in a Medical Device/Pharmaceutical Industry
  • Excellent knowledge of ISO 13485, CE and FDA requirements, with experience supporting regulatory submissions
  • Experience dealing with Notified Bodies relating to Medical Devices
  • Experience In technical file writing
  • Proven track record of regulatory submissions of technical files
  • Experience in CAPA system management
  • Six Sigma training desirable
  • Regulatory experience and knowledge in the following areas; medicinal, medical, cosmetic and food supplement
  • GMP Experience
  • Ability to work independently, prioritizes multiple projects, addresses multiple issues, and handles multiple deadlines, in a hands-on environment
  • Good supervisory, technical writing and investigation skills
  • Excellent communication and inter-personal skills
  • Strong planning and organizational ability
  • The ability to carry out work in a fast-paced organisation
  • Ability to influence peers and colleagues and ensure that they understand with great clarity what is expected from them from the quality and regulatory department. Ensuring colleagues understand the why are supportive of the needs of the Q&R department