Job Summary
A medical device consultancy company is seeking a Remote Medical Device Regulatory and Quality Consulting Manager.
Individual must be able to fulfill the following responsibilities:
- Provide proactive guidance to clients and medical device project teams
- Provide technical guidance in the development of marketing activities
- Guide clients and employees on complex regulatory and quality situations
Applicants must meet the following qualifications:
- Degree in relevant discipline: Biochemistry, Molecular Genetics, etc
- 10+ years post-graduate experience relevant to IVDs
- 5 years experience in either new product development in IVD industry or in a diagnostics lab
- Understanding of requirements for performance evaluation of in vitro diagnostic devices
- Ability to analyse and interpret complex data sets relevant to IVDs compliance
