Senior Manager Medical Affairs (m/f/d)

Baxter Medical Systems enables excellence in surgical procedures in modern medical technology. From emergency care to critical care, our products help care teams achieve outstanding results. To enable surgical staff and multidisciplinary care teams to work efficiently, digital systems are automated and devices are essential to streamline processes, increase user convenience and improve patient safety. Baxter takes this development into account and sets new standards with its intelligent and networked solutions.

We are currently searching a Senior Manager Medical Affairs (m/f/d) based in Munich or Saalfeld (Thuringia).

• 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.
• Indepth knowledge of EMDUR clinical documentation requirements including, but not limited to safety and performance criteria, intended use etc.
• 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.
• Supports legal and regulatory and quality requirements related to R&D and product lifecycle management.
• Maintains compliance with current standard operating procedures.
• Assumes other duties and responsibilities as assigned by manager/supervisor.
• Clinical core competency for related products.
• Technical core competency for related products.
• Legal and regulatory core competency for related products.

• Bachelor’s degree or advanced degree (BSN, MSN, DNP, RN) in Health or Science field preferred
• Minimum 5 years of relevant Industry experience required
• Excellent written, oral communication, and organizational skills.
• Effective and competent presentation and teaching skills.
• Self-motivated, independent, mulit-tasking, team-oriented individual with exceptional follow through. - Industry experience preferred
• Degree in related clinical discipline or equivalent required
• Experienced and skilled Nurse/Practitioner with significant surgical device background required.
• Active license or regional equivalent in good standing required.
• Minimum 5 years of related Surgical experience required.
• 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. - Industry experience preferred
• Indepth knowledge of class I and II device registration including EMDUR and FDA, clinical document SME (CEP/CER/PMS)
• 3 day a week in office, two days remote/Munich and/or Saalfeld Germany
• Travel required domestic and internationally may be up to 50%
• Fluent in German and English languages