- Location
- Cleveland, OH
- Workplace
- Hybrid
- Department
- Legal
- Seniority
- Director
- Source
- PCRecruiter
Description
A growing medical testing company in the Cleveland, OH area is seeking a senior regulatory affairs leader to guide strategy and execution for in vitro test and laboratory-developed products across development, approval, and commercialization. The role is expected to follow a hybrid working model, with regular access to the Cleveland office.
This leader will direct FDA submissions and agency interactions, assess product and manufacturing changes, coordinate clinical and analytical evidence, support post-market and quality-system compliance, and oversee submission controls. Candidates should bring at least ten years of progressive regulatory experience, substantial FDA-regulated IVD experience, and demonstrated leadership of submissions such as PMAs, supplements, 510(k)s, and pre-submissions.