Purpose and Essential Duties 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.

• 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 for issues specifically impacting in vitro diagnostic companies (spanning pre to postmarket) as well as devising and implementing key medical device priority activities on advertising and promotion and other emerging issue areas
• Leads multiple AdvaMed working groups in selecting, discussing and reviewing issues, establishing priorities, and implementing programs; provide technical assistance and guidance
• Monitors scientific/regulatory activities and communicates information to members
• Organizes and participate in workshops, educational programs and roundtable programs on priority regulatory topics; edits proceedings
• Creates new resource materials and updates for AdvaMed
• Advises AdvaMed staff on key technical and regulatory issues of concern to manufacturers
• Provides technical guidance and support for AdvaMed’s work in product safety, domestic and international regulation, and user education
• Represents Association’s positions to government agencies, standards organizations, industry professionals, academics and other groups
• Travel Requirements: 5%

Knowledge, Skills, and Abilities (KSAs)

• Excellent oral, 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 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:  Bachelor’s degree required; advanced degree strongly preferred
• Minimum Experience Required:  6+ years, with experience in the medical device industry and with the FDA

Physical Requirements

• Standard AdvaMed Office Position