Vice President, MedTech Cardiovascular Regulatory Affairs
Core
Lead regulatory strategy and submissions for medical device clients, managing department operations and business development.
Role type
Senior leadership regulatory affairs executive
Builds
Regulatory submissions (510(k), IDE, PMA, IND, BLA), technical documentation, and clinical trial strategies for cardiovascular and other medical devices
Domain
MedTech / Cardiovascular / Regulatory Affairs
Required skills
Regulatory strategy, submission development, team management, business development, client relations, pre-clinical testing oversight, FDA/ISO 13485 fluency, medical/technical writing, project leadership
Preferred skills
MS or PhD, clinical research understanding, statistical analysis, engineering/biological background
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
VP, strategic leadership & people management