Associate Vice President, Technology & Regulatory Affairs - Washington, DC | Biospace
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Associate Vice President, Technology & Regulatory Affairs

Advanced Medical Technology Association

Location:
Washington, DC
Posted Date:
11/18/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Regulatory Affairs,

Job Description

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 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%

Requirements

Knowledge, Skills, and Abilities (KSA’s)
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
Bachelor’s degree; advanced degree strongly preferred

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