Vice President, Technology & Regulatory Affairs

11 Apr, 2019

Jobs

Vice President, Technology & Regulatory Affairs

AdvaMed
Washington, DC
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.  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.  Creates 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

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: 10+ years, with experience in the medical device industry and with the FDA

Learn more here

Job posted: 2019-04-11