Technology & Regulatory Affairs (04) / Senior Advisor to the President & Senior Executive Vice President, Technology & Regulatory Affairs
FLSA Status
Exempt
Purpose of Position
To advance and achieve member policy objectives on key technical and regulatory issues of concern to manufacturers. To provide substantial expertise, assistance and representation on technical, regulatory, and scientific issues related to medical devices.
Essential Duties of Position
Represents AdvaMed’s positions and fosters and maintains key relationships with FDA and other stakeholders to leverage/support AdvaMed priorities (e.g., testimony, presentation, face to face meetings)
Strategizes, advises, and develops consensus policy to promote medical device industry priorities, including directing technical, regulatory, and scientific policy development. Supervises and leads multiple AdvaMed working groups in selecting, discussing, and reviewing issues, establishing priorities, and implementing programs; provide technical assistance and guidance
Serves as staff liaison and lead on regulatory items, closely managing and maintaining AdvaMed’s relationship with the FDA; serves as a leader, building trust and consensus among members, AdvaMed staff, and the FDA
Monitors scientific/regulatory activities and communicates information to members
Organizes and participates in workshops, educational programs, and programs on priority regulatory topics. Designs new resource materials and updates for AdvaMed
Advises AdvaMed staff on key technical and regulatory issues of concern to manufacturers
Represents Association’s positions to government agencies, industry professionals, academics, and other groups
Knowledge, Skills, and Abilities
Excellent verbal, written, and presentation skills, especially persuasive writing
Knowledge of medical technology and regulation
Excellent analytical, organizational, and persuasive skills
Exceptional ability to synthesize, interpret, and summarize information
Leadership and teambuilding skills
Excellent supervisory skills
Excellent diplomacy skills
Ability to organize, plan, and prioritize workload, and manage multiple competing projects
Ability to establish and maintain effective working relationships with others
Knowledge of and familiarity with the medical device industry and government relationships
Proficient in the use of relevant Microsoft Office Suite software
