Preclinical Development Expert

7 ore fa

Abano Terme, Italia Fidia Farmaceutici A tempo pieno

Founded in 1946 Fidia is a fully integrated Italian multinational company, with R&D, Manufacturing, Marketing and Sales capabilities headquartered in Abano Terme. Fidia is prioritizing its R&D efforts in areas with the greatest scientific and commercial promise, such as Joint Care, Eye Care, Skin Care, Aesthetic Care, Regenerative Care, Primary Care and Specialty Care.

To strengthen our Preclinical Development team at Fidia's headquarters in Abano Terme, we are looking for a

**Preclinical Development Expert**

You'll support the Preclinical Development Manager and the team in activities related to the development of new medical devices for Regenerative Care, maintaining regulatory compliance for marketed medical devices or the design of new devices, and preparing preclinical documentation related to regulatory compliance for medical devices across the company.

**Main responsibilities**:

- Follow the development of the design and ensure that it is carried out in accordance with Fidia SOPs and the requirements of applicable regulations and standards.
- Document the design progress according to Fidia SOPs (i.e. design history file).
- Ensure that the risk management activities are carried out according to the attainment of the highest degree of safety of the project.
- Report to the Preclinical Development Manager & Project Leader on the progress of design activities and any deviations from the approved plan.
- Support the functions responsible for drafting the investigator’s brochures required for the initiation and maintenance of clinical studies.
- Support the resolution of technical complaints and change controls when the product design is involved or impacted.
- Analyzing any gap related to the medical device pointing out the need to perform preclinical studies to meet current regulations.
- Elaborate and update of the Biological Evaluation for the toxicological and preclinical safety assessment of new and already marketed medical devices, according to applicable regulatory standards.

**Requirements**:

- Master's degree in Biology, Biotechnology, Chemistry, Pharmaceutical Chemistry and Technology, Pharmacy or Biomedical Engineering and preferably a PhD.
- 6 months of work experience in a pharmaceutical or biotech company, in R&D, quality or regulatory departments.
- Project management skills will be considered a plus.
- Fluency in English.
- Critical thinking and communication skills, as well as the ability to work in a team and show initiative.

**Our offer**:

- Open-ended contract.
- “C” grading of chemical pharmaceutical national collective contract.
- Salary between € 32.000 and € 33.000.
- Collective Bonus and company Welfare.

**Fidia benefits**:
In Fidia you will have unlimited access to training and coaching programs aligned with market best practices and opportunities for professional development through participation in internal job posting processes, pension fund with company integration and health fund, merit review and referral programs, company canteen, staff discounts and access to the flu vaccination campaign.
- Fidia Farmaceutici promotes parity and inclusion in all its actions._
- All company procedures are therefore drafted in compliance with the principles expressed in the previous point; any divergences should be promptly brought to the attention of the People & Culture Department._

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