Hybrid Senior Manager, Medical Affairs

at Baxter International Inc.

• Job title: Senior Manager, Medical Affairs
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Munich, Germany

About the role

• Senior Manager Medical Affairs providing clinical development and launch expertise in surgical medical devices. Leading collaborations with cross-functional partners for efficient product support in Germany.

Responsibilities

• Serve as the medical device subject matter expert to both internal and external customers for product development, risk assessment, training, implementation, literature reviews, complaints, safety signals, field action, voice of the customer, and voice of the business.
• Devise novel approaches to address clinical and technical problems in clinical practice through development and modification of related medical devices.
• 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, clinical experience, and voice of the customer.
• Assimilate voice of customer and clinical experience for design input with new product development and product lifecycle management.
• Provide clinical expertise for creation and development of risk assessments and quality standards for product design history files.
• 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 planning, when applicable.
• Maintain familiarity of published literature as objective evidence for clinical trends and therapies related to impact on product lines.
• Understands and adheres to internal and external complaint and adverse events handling requirements, including standard response communications.

Requirements

• Minimum 5 years of related Surgical experience required.
• Experienced and skilled Nurse/Practitioner with significant surgical device background required.
• Active license or regional equivalent in good standing required.
• Degree in related clinical discipline or equivalent required.
• In-depth knowledge of class I and II device registration including EMDUR and FDA, clinical document SME (CEP/CER/PMS).
• Excellent written, oral communication, and organizational skills.
• Effective and competent presentation and teaching skills.
• Self-motivated, independent, multi-tasking, team-oriented individual with exceptional follow through.
• Experience with surgical tables, lights, table accessories, and booms systems along with healthcare information technology implementation and training preferred.
• Knowledge of Baxter products and competitive products preferred.

Benefits

• 30 days vacation plus special leave
• above-average social benefits
• company pension scheme
• share plan for employees
• professional training opportunities