Junior Expert Drug Regulatory Affairs (m/w/d)
at Fresenius Medical Care
6BHVDH, Hessen, Germany -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 22 Jan, 2025 | Not Specified | 23 Oct, 2024 | N/A | Professional Development | 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:
Are you ready to make a significant impact in the ever-evolving medical technology industry? As a Junior Expert in Drug Regulatory Affairs, you’ll play a crucial role in ensuring that cutting-edge medical products meet regulatory standards across global markets. This position offers you the opportunity to collaborate with multiple departments—such as Quality Control, Manufacturing, and Clinical Research—while honing your expertise in regulatory processes, dossier preparation, and compliance. If you’re driven by precision, passionate about healthcare innovation, and eager to contribute to global health solutions, this is the perfect role for you.
Responsibilities:
- Support and preparation of approval dossiers in accordance with country-specific requirements
- Updating the marketing authorization dossiers
- Support in the processing of deficiency notifications and change notifications worldwide
- Support in Creation, review and approval of product information texts
- Support in the implementation of approval requirements in the Quality Control, Manufacturing, Quality Assurance and Clinical Research departments
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Proficient
1
61352 Bad Homburg vor der Höhe, Germany