Handle all regulatory aspects for assigned Business Unit. Participates on product development teams, including new product, geographic expansion, and maintenance of business. Interacts with Regulatory Authorities and interfaces frequently with B+L regional regulatory partners.
Scope of Position:
Focus slightly weighted to EU MDR submission work.
Balance is roughly 60% International and 40% domestic.
Key Relationships: Internal Global and regional Regulatory Affairs partners, as well as internal cross-functional interacts with external regulatory authorities.
Bachelor’s degree in science or health related field required.
Preferred Education: Advance degree preferred (PhD, MD, MS, PharmD, or equivalent)
Must possess at least a mastery level of performance in the majority of the following core competencies: influence key stake holders, business acumen, project management, relationship building, regulatory expertise.
Preferred Skills/Qualifications: Regulatory Affairs Certification
7-10 years regulatory experience with medical devices
Preferred Experience: 10+ years regulatory experience with medical devices