Biological Safety and Compliance Specialist

il y a 2 jours


Grenoble, France Corin Temps plein

**Biological Safety and Compliance Specialist**

We are looking for a Biological Safety and Compliance Specialist to join us on a permanent basis. Providing support to the Biological Compliance team, you will be liaising with other team members and staff in the Group to maintain on-going regulatory compliance of the Biological Safety Evaluation programme for all Corin products.

This role will offer you the opportunity to gain experience of the wide range of Corin hip, knee, and ankle implants and the associated instruments and to work with a high degree of autonomy within the established Corin systems.

This role can be either based at our head office in based in Cirencester, UK or Grenoble in France; we can offer hybrid working or fully remote working. You will need to have the appropriate working rights to work in either country.

**The key responsibilities of the Biological Safety and Compliance Specialist are to support the Biological Compliance Team and to**:

- Developing and maintaining documented systems for the performance of Biological Safety Evaluations for Corin medical devices
- Writing Biological Evaluation plans and reports that comply with the ISO 10993 series and FDA requirements for Class III implantable devices and Class 1r, IIa and IIb medical devices
- Maintaining appropriate records supporting biological safety and present these at audits if required
- Reviewing engineering changes to design, materials, and manufacturing processing aids to assess and document the impact to the biological evaluation report and biosafety of the device
- Liaising with consultant toxicologists and external test laboratories to plan and conduct testing pertaining to biosafety of devices
- Supporting vigilance activities when requested with expert advice on any biological safety risks associated with events
- Supporting New Product Introduction by providing biological safety data to support launch of new products to project timelines and if necessary, presenting and discussing this data with regulators.
- Communicating progress at team meetings and chair meetings for key projects

**Requirements**:
**As Biological Safety and Compliance Specialist, you will have**:

- A good understanding of the current requirements for demonstrating Biological Safety of medical devices
- Knowledge of Quality Management Systems i.e. FDA QSR, ISO13485 or ISO9001
- Excellent communication skills with internal and external stakeholders



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