Searching for skilled and experienced people within the Medical Device area
Pharma IT is for a customer investigating the possibility of establishing a privately owned Notified Body in Denmark.
To support such a setup a wide range of skilled and experienced ressources within the Medical Device area is needed.
Pharma IT is therefore searching for skilled and experienced people within the Medical Device area that would be interested in a part/full time position or consultant/freelance setup for a Notified Body located in Denmark. The business model will be cloud based so it is not a requirement to be living in Denmark.
We are specifically looking for people within the following areas who can fulfill the requirements of EU REGULATION 2017/2185 – Link:
- Personel to perform conformity assessment and final conclusion review on certification
- Personel with clinical expertise, i.e. review of clinical documentation for clinical evaluation, biological safety
- Personel to perform product related reviews i.e. review of technical documentation, sterilisation, software validation
- Personel to perform audits of manufacture quality management system