Manager – Medical Affairs

Manager – Medical Affairs

Requirements

• Minimum 5 years of related clinical experience required; industry experience preferred.
• Degree in related clinical field (Advanced Degree Preferred) or proven experience required.
• NP/PA/MD with primary and/or acute care experience such as ER, Urgent Care, or Hospitalist/internal medicine is ideal.
• Optometrist who displays sophisticated knowledge of physical assessment will be considered.
• Medical Affairs proven experience highly preferred.
• Active license in a U.S. state or territory in standing required with clinical expertise.
• Excellent written, verbal communication, and organizational skills.
• Effective and proficient presentation and teaching skills.
• Self-motivated, multi-tasking, with outstanding follow through.
• Ability to travel frequently (Up to 50%) domestically and occasionally internationally.

Responsibilities

• Serve as the medical and device subject matter expert to both internal and external customers for product development, risk assessment, training, implementation, literature reviews, and complaints.
• Provide accurate, balanced and timely clinical expertise to functional areas such as clinical development, R&D, marketing, manufacturing, quality assurance, regulatory affairs, and legal based on objective evidence and, clinical experience.
• Provide clinical expertise for creation and development of risk assessments and quality standards for product design history files.
• Devise novel approaches to address clinical and technical problems in clinical practice through development and modification of related medical devices.
• Assimilate voice of customer and clinical experience for design input with new product development and product lifecycle management.
• Develop and deliver relevant medical device training programs (e.g. written, verbal, and eLearning) that support product implementation, training, and marketing efforts.
• Train internal customers on product application, disease states, and regional differences as required.
• Support product implementation process creation, maintenance, and controlled launch when applicable.
• Maintain familiarity of published literature as objective evidence for clinical trends and therapies related to impact on product lines.
• Coordinate with other Medical Partners (e.g., Clinical Research, Clinical Operations, HEOR, Regional Medical, etc.) as needed to support Division Medical efforts.

Preferred Qualifications

• Industry experience preferred.
• Advanced Degree Preferred.