Senior Regulatory Engineer (HU)
at Omixon Inc
Budapest, Közép-Magyarország, Hungary -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 03 Dec, 2024 | Not Specified | 04 Sep, 2024 | 3 year(s) or above | Analytical Skills,Iso,Molecular Biology,Immunology,Genetics | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
OPT | H4 Spouse of H1B |
GC Green Card |
Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
OUR GOAL IS TO IMPROVE THE LIVES OF THOUSANDS OF PATIENTS THROUGH OUR TRANSPLANTATION DIAGNOSTICS TESTS. THIS IS WHAT INSPIRES US.
The Senior Regulatory Engineer focuses on IVD medical device quality assurance. The incumbent will report to the Chief Technical Officer and work closely with other departments as well.
REQUIRED QUALIFICATIONS AND SKILLS:
- MSc in Life Science
- Minimum 3 years of quality and regulatory experience in the medical device field (or similar: pharma)
- Experience with ISO 13485, CE marking, FDA approval
- Self-motivated, works well with minimal supervision
- Strong analytical skills and knowledge of statistical methods
- Sound problem-solving skills
- Advanced English
ADVANTAGEOUS SKILLS
- Experience in the fields of molecular biology, genetics, immunology
- Experience with clinical studies
Responsibilities:
REQUIREMENT SUMMARY
Min:3.0Max:8.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
MSc
Proficient
1
Budapest, Hungary