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TTM have an exciting opportunity with a national semi-state body recruiting an Industry Engagement Officer for Medical Devices.
The Industry Engagement Officer will report to the Director of Medical Devices in Ireland and will work closely with the Vice president in the USA. The role will be based in either Dublin or Galway with an element of national and international travel involved within this role. This is an exciting opportunity for someone who is dynamic and enthusiastic about medical technology.
The Industry Engagement Officer will liaise with medical device companies and be the first point of contact for technical queries relating to medical device certification.
Benefits:
Competitive Salary
Hybrid
Flexible working options
30 days annual leave
Pension
Job Overview
The Medical Devices department is a notified body for the following schemes:
• Medical Devices Directive 93/42/EEC,
• Active Implantable Medical Devices Directive 90/385/EEC,
• In Vitro Diagnostic Medical Devices Directive 98/79/EC,
• Commission Regulation 722/2012,
• Human Blood/ Plasma, 2000/70/EC,
• Medical Devices Regulation 2017/745,
And is accredited to the following assessment services:
• MDSAP Recognised Auditing Organization,
• ISO 13485 Certification Body Auditing,
• ISO 9001 Certification Body Auditing.
Key Tasks and Responsibilities:
• Act as primary point of contact for all new business enquiries worldwide
• Process new business enquiries through the customer relations management software
• Perform contract review as per ISO 17021/ MDR2017/745/, IVDR 2017/745/ MDSAP
• Provide quotation service for new business enquiries
• Liaise with client service representatives' and medical device operations managers to aid in scheduling audits and product reviews
• Act as point of contact for existing clients seeking status updates on audits and product reviews
• Represent NSAI at national and international conferences
• Act as key client manager
• Support the transition of existing clients from the MDD/IVDD into the MDR/ IVDR through contracting, quotation and scheduling activities
• Keep abreast with the Irish, UK and USA Medtech sector
Qualifications and Experience:
Essential
Successful completion of a university or a technical college degree or equivalent qualification in relevant studies i.e. science, engineering, healthcare related studies
Four years professional experience in the field of healthcare products or related activities, such as manufacturing, auditing or research of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be evaluated.
Technical Competencies:
Knowledge of Medical Device legislation, harmonised standards, guidance documents
Knowledge of the Medical Device Regulation In vitro diagnostic regulation
Knowledge and experience of contract review and quotation
Excellent presentation skills
Strong understanding of international regulatory requirements for medical devices, with particular emphasis on European, UK requirements and MDSAP
Ability to analyse data and write clear, concise summary reports
Apply Now with an updated CV or contact Grace on grace.kilroy@ttmhealthcare.com or call 065 6869800 Ext. 215 For more information
TTM Healthcare Solutions is an Equal Opportunities Employer
Expired job
Industry Engagement Officer - Medical Devices
| Location | Galway |
| Job-type | Permanent |
| Salary | €68676 - €99638 per annum |
| Contact | Grace Kilroy |
| email Grace | |
| Reference | J366057 |
| Date Published | 6 months ago |
The Industry Engagement Officer will report to the Director of Medical Devices in Ireland and will work closely with the Vice president in the USA. The role will be based in either Dublin or Galway with an element of national and international travel involved within this role. This is an exciting opportunity for someone who is dynamic and enthusiastic about medical technology.
The Industry Engagement Officer will liaise with medical device companies and be the first point of contact for technical queries relating to medical device certification.
Benefits:
Competitive Salary
Hybrid
Flexible working options
30 days annual leave
Pension
Job Overview
The Medical Devices department is a notified body for the following schemes:
• Medical Devices Directive 93/42/EEC,
• Active Implantable Medical Devices Directive 90/385/EEC,
• In Vitro Diagnostic Medical Devices Directive 98/79/EC,
• Commission Regulation 722/2012,
• Human Blood/ Plasma, 2000/70/EC,
• Medical Devices Regulation 2017/745,
And is accredited to the following assessment services:
• MDSAP Recognised Auditing Organization,
• ISO 13485 Certification Body Auditing,
• ISO 9001 Certification Body Auditing.
Key Tasks and Responsibilities:
• Act as primary point of contact for all new business enquiries worldwide
• Process new business enquiries through the customer relations management software
• Perform contract review as per ISO 17021/ MDR2017/745/, IVDR 2017/745/ MDSAP
• Provide quotation service for new business enquiries
• Liaise with client service representatives' and medical device operations managers to aid in scheduling audits and product reviews
• Act as point of contact for existing clients seeking status updates on audits and product reviews
• Represent NSAI at national and international conferences
• Act as key client manager
• Support the transition of existing clients from the MDD/IVDD into the MDR/ IVDR through contracting, quotation and scheduling activities
• Keep abreast with the Irish, UK and USA Medtech sector
Qualifications and Experience:
Essential
Successful completion of a university or a technical college degree or equivalent qualification in relevant studies i.e. science, engineering, healthcare related studies
Four years professional experience in the field of healthcare products or related activities, such as manufacturing, auditing or research of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be evaluated.
Technical Competencies:
Knowledge of Medical Device legislation, harmonised standards, guidance documents
Knowledge of the Medical Device Regulation In vitro diagnostic regulation
Knowledge and experience of contract review and quotation
Excellent presentation skills
Strong understanding of international regulatory requirements for medical devices, with particular emphasis on European, UK requirements and MDSAP
Ability to analyse data and write clear, concise summary reports
Apply Now with an updated CV or contact Grace on grace.kilroy@ttmhealthcare.com or call 065 6869800 Ext. 215 For more information
TTM Healthcare Solutions is an Equal Opportunities Employer
Expired job