Director, Regulatory Counsel
Core
Director of Regulatory Counsel providing legal guidance on advertising, fraud/abuse, clinical contracts, and state licensing for a medical device company.
Role type
Senior in-house legal counsel (Director level)
Builds
Legal compliance frameworks, contract templates, and regulatory knowledge bases for the Healthcare Regulatory team
Domain
Healthcare / Medical Devices / Life Sciences
Required skills
Juris Doctor, 8+ years legal experience, regulatory compliance analysis, contract negotiation, fraud and abuse law, clinical trial legal issues, strategic thinking, risk assessment
Preferred skills
Life sciences/MedTech/pharmaceuticals industry background, advertising/promotion experience in medical devices, fraud and abuse counsel experience in healthcare
Technologies
None stated
Responsibilities
Review and approve advertising and promotion materials for regulatory compliance; Provide advice on fraud and abuse issues; Review and advise on clinical contracts and trials; Negotiate strategic clinical and commercial contracts; Develop standard processes and templates for the regulatory team; Deliver legal education to business colleagues; Monitor legal developments in the medical device space
Seniority
Director, Senior IC with strategic oversight