A global Medical Device Manufacturing company, based out of Ohio is looking to add a Senior Regulatory Specialist/Specialist to their evolving team. This IVD focused organization is looking for a Regulatory professional to join either their pre-market or international team.
Responsibilities:
- Work collaboratively with related departments within the organization (Quality, Engineering, etc)
- Perform tasks related to new product development
- Comply with Regulatory Health Authority standards in product related submissions/review
Qualifications:
- 2 to 5 years within Regulatory Affairs or related field
- Hands on 510k experience
- Working knowledge of EUMDR gap analysis
- Knowledge of relevant ISO standards
If you are interested in pursuing this position, please apply here.
