Team Assistant (m/f/d) for our Regulatory Affairs Team
at Olympus Europa SE Co KG
Hamburg, Hamburg, Germany -
| Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
|---|---|---|---|---|---|---|---|
| Immediate | 28 Jun, 2024 | Not Specified | 29 Mar, 2024 | N/A | Good communication skills | 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:
Your responsibilities
- Responsible for regulatory affairs activities to assist in regulatory submission (new registrations, renewals and change registrations)
- Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards
- Assist in creation and maintenance of regulatory files
- Write, analyze and edit technical documents to support country specific regulatory submissions
- Maintenance of technical files
- Assist in data management within PLM system and SAP
- Organize required certifications with external partners (FSCs, Notary, Apostille)
- Process management
Your qualification
- First administrative experience
- Relevant education like industrial business management assistant, Bachelor or Master in a relevant field
- Good communication skills in English, German language skills are nice to have
- First experience working with data bases
- Knowledge of office software applications
- Teamplayer in an international environment
- Open to working with international teams
Your benefits
- A comprehensive company pension scheme
- Employee restaurant with live cooking and healthy food (subsidized) as well as fully equipped office kitchens
- Christmas Bonus & Holiday Pay
- Employee Assistance Program & famPLUS
- Corporate Health Care
- Subsidized public transport ticket
- Flexible Working Time
- Various company sports groups
- Bike leasing (JobRad)
- Capital-forming Payments
- 30 days of holiday
- Up to 60 % mobile working possible
Responsibilities:
- Responsible for regulatory affairs activities to assist in regulatory submission (new registrations, renewals and change registrations)
- Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards
- Assist in creation and maintenance of regulatory files
- Write, analyze and edit technical documents to support country specific regulatory submissions
- Maintenance of technical files
- Assist in data management within PLM system and SAP
- Organize required certifications with external partners (FSCs, Notary, Apostille)
- Process managemen
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Hospital/Health Care
Pharma / Biotech / Healthcare / Medical / R&D
Health Care
Graduate
Proficient
1
Hamburg, Germany
