Breve introduzione: Are you a specialist in the healthcare or medical devices sector?
Have you ever thought of using your specialism to contribute to the safety and performance of medical devices according to the European Medical Device Regulation?
We are searching for an expert in the area of Orthopaedics-spinal implants, bone cements, Dental Implants and soft tissue implants.
Do you want to further build on your experience in an ambitious international company?
Then you might well be Kiwa's new Medical Devices Product reviewer.
Descrizione del ruolo:
In the role of Product reviewer, you are responsible for the assessment of the Technical Documentation of the medical devices of our customers.
You will perform Product reviews according to the Medical Device Regulation (MDR) evaluating for example at the design and construction, risk management, post-market surveillance results, clinical evaluation and usability of the medical products.
Our clients range from highly innovative start-ups to large companies, both national and international with a wide range of medical devices.
After an extensive internal training program, you:
- Execute Technical File assessments as a Product reviewer;
- Contribute to the specific aspects relevant to your expertise, such clinical data, biological safety, sterilization and software, during assessment;
- Are responsible for the periodical Technical Files assessments, State of the art reviews and the Vigilance and Change Notifications of your customers;
- Maintain contact with the customer concerning the Product review outcome and required follow up;
- Maintain contact with your colleagues, external experts and contractors;
- Provide advise and mentoring to colleagues in your area of competence;
- Provide the audit team with expert input and write test plans for unannounced audits;
- Will work at the company office or remote from home.
Cosa ci aspettiamo da voi:
You want to take a new step in your career and are interested to further develop your knowledge and skills.
You are ready to receive an internal training program to become qualified as Kiwa Medical device Product reviewer.
You get energy from contributing to the quality and safety of products.
You can work independently as well as in a team and take ownership for your work, completing all chargeable work assigned in the timeframe assuring efficient and effectiveness service.
You have good communication skills, project management skills, informing and reporting to stakeholders in a clear and timely manner.
For this position, we'd like you to bring these educational and personal skills:
- A PhD., MSc.
or BSc.
in a relevant product or medical area: Biomedical or mechanical engineering, physics, biotechnology, biomaterials, medicine, odontoiatric and relevant sciences;
- A minimum of 4 years' experience in the field of healthcare products or related activities, such as in manufacturing, auditing, assessment or research of which a minimum of 2 years shall be in design, manufacture, testing, conformity assessment or use of the Orthopaedics-spinal implants, bone cements/ Dental implant, bone substitutive and soft tissue implants or technologies to be assessed or related to the scientific aspects to be assessed;
- Experience with risk management according to ISO 14971;
- Experience with harmonized medical device standards, CS and MDCG documents for non-active devices;
- Experience with Sterilization techniques (such EtO, Radiation, Steam, Asepsi, Plasma Dry heat, etc);
- Experience on clinical data evaluation;
- Experience as product assessor already qualified by Notified Body is an advantage;
- Experience with other non-active device or related product is an advantage;
- English language skills are required, German/French/Spanish are valued;
- You are based in Italy and are entitled to work here.
Cosa offriamo noi in cambio:
As a Product reviewer at Kiwa, you'll hold a challenging position in a technically oriented, ambitious, expanding international Notified Body organisation.
At Kiwa, we value your professional development and personal wellbeing.
You'll be given ample opportunities to balance your working and private life.
When it comes to our terms and conditions, we offer you a salary tailored to your professional competence and experience including important benefits such as:
- Luncheon vouchers
- Annual welfare vouchers
- Additional health insurance
- Comprehensive training programme
- Eligibility for Career pathways
**Where you'll work**
In this role, you will work for Kiwa Cermet Italia, based in Cadriano (BO).
You will be part of the Medical Devices team: a friendly, close-knit, professional team made up by over 30 very skilled people.
You will work for and report to the Technical Certification Manager of the Medical Devices Division.
**More information**
We look forward to hearing from you!