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
james.cassidy@lifescience.ie
Connect with me on
Buyer
Cork
API Purchaser
Dublin
R&D Engineer
Dublin
Head of Quality
Dublin West
R&D Engineer
Galway
Program Manager
Westmeath
QA Manager
Dublin North
QA Manager
Dublin West
Snr QA Specialist
Dublin South
QA Manager Biologics
Dublin West
QA Manager
Meath
Biostatistician
Dublin City Centre
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 applications@lifescience.ie
Details

Active Devices Product Technical Specialist / Scheme Manager


Reference:JC/HQ00001764 Location: Republic of Ireland
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

We are currently working on an exciting opportunity with world renowned notified body. Who are seeking a Technical Specialist/Scheme Manager in the area of Active Devices to join their team. Reporting to the global head of active devices this role can be a home based role or office based globally.

Role/Responsibilities

To manage a portfolio of Medical Device CE marking clients.
Plan and deliver Technical File Assessments and Unannounced Audits in support of EC Certification
Manage client projects, acting as their primary contact and after satisfactory assessment make certification recommendations for CE certificate issue
Act as technical support to the commercial team when required
Provide in-house and external training in areas of expertise
Deliver Medical Device CE Technical File Assessment services from office, and on-site as a fully integrated member of the Active Devices Team
Perform Unannounced visits to medical device manufacturers globally as a technical expert
Support the Commercial Team as it grows the customer base worldwide
Delivery of all services within required timescales and to a high quality
Maintaining client satisfaction whilst continuing to meet ethical expectations
Performing in-house training
Maintain and expand competence in areas of technical expertise and Medical Devices certification
The jobholder will be a member of the Active Devices Team reporting to the Global Head, Active Devices and work as a colleague with other members of the Medical Devices Business Stream.
There is interface at all levels of management in client and regulatory organisations.
Some global travel is expected to perform technical assessments, unannounced visits and to attend relevant meetings and training.

Skills/Experience

BSc degree or PhD, or equivalent qualification, in a discipline relevant to medical device manufacture and use
4+ years of Medical Device experience in a technical capacity, preferably within product design, development and testing; manufacturing experience also advantageous.
Interpretation and applications of International and National standards for the design, manufacture and regulation of medical devices.
Understanding of Risk Management and FMEA of Electromedical Devices
Conceptual and analytical thinking, efficiency and results orientation
Ability to work independently with minimal supervision; self-motivated.
A team player good at relationship building internally and externally
Broad technical understanding of electromedical devices. Understanding of companies operating in these spaces and current industry trends.
Thorough knowledge of Medical Device regulation and Knowledge of QMS systems for medical devices would be advantageous.
English as a minimum.



James Cassidy | Tel: +353 (0) 1 5079250