Vice President, MedTech Cardiovascular Regulatory Affairs
Core
Leading regulatory strategy and submissions for medical device and diagnostics clients, managing department operations, and acting as a primary contact for regulatory bodies.
Role type
Vice President, MedTech Cardiovascular Regulatory Affairs
Builds
Regulatory submissions (510(k), IDE, PMA, IND, BLA), technical documentation, and strategic regulatory plans for medical device clients.
Domain
MedTech, Cardiovascular, Regulatory Affairs
Deliverable
client delivery
Required skills
Regulatory strategy development, managing regulatory submissions, team leadership and mentorship, business development, client relationship management, pre-clinical testing oversight, cross-functional collaboration, project management, medical/technical writing, statistical analysis, problem-solving
Preferred skills
MS or PhD in scientific/engineering/regulatory discipline, domain-specific therapeutic expertise, experience with international regulations (ISO 13485, Notified Bodies)
Technologies
MS Office, Excel, Word, PowerPoint
Responsibilities
Manage and grow department/team including budgets and hiring; Develop and execute regulatory services and submissions; Lead prospecting and business development; Act as primary contact for clients and regulatory bodies; Mentor junior employees; Collaborate with clinical, compliance, and quality assurance departments
Seniority
Executive, strategic leadership & mentorship