Position Title: Vice President, Technology & Regulatory Affairs

Department: Technology & Regulatory Affairs (04)

Supervisor: Senior Executive Vice President, Technology & Regulatory Affairs

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.  Ability to telework, minimum one day per week onsite.

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 Associations positions to government agencies, industry professionals, academics, and other groups
• Travel Requirements: 5%

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

Specifications

• Minimum Education Required: Bachelors degree required; advanced degree strongly preferred
• Minimum Experience Required: 10+ years, with experience in the medical device industry and with the FDA