Instrument Company Liaison Strategic Manager, Medical Affairs

Requirements

• Project management skills with ability to work independently
• Working knowledge of Laboratory Medicine practice, Quality Assurance, Regulatory or Quality compliance activities in a medical device or similar industry
• Strong inter-department coordination skills, public speaking, time management, and activity management required
• Familiarity with in vitro diagnostics in a clinical or academic setting and knowledge of medical/technical terminology
• Familiarity with BD SM products a plus
• Strong critical thinking, strategic assessment, and analytical and problem-solving skills
• Excellent verbal and written communications, professionalism, and interpersonal skills
• Ability to deal with ambiguity
• Required Education/Experience
• Clinical Pathology or, Clinical Chemistry with MD or PhD degree.
• Minimum 4+ years of experience in Medical Affairs, R&D or Clinical Laboratory in chemistry or hematology.
• Professional certification is a plus.
• At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum

Benefits

Additional Information

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. Job Description BD Instrument Company Liaison Strategic Manager, Medical Affairs The Instrument Company Liaison (ICL) Strategic Manager, Medical Affairs for Specimen Management (SM), represents MA function in the cross-functional Instrument Company Liaison Team, which is responsible for developing and executing BD SM strategy for major and different instrument companies' collaboration. ICL Strategic Manager serves as an internal cross-functional scientific liaison across BD SM MA, R&D, Marketing, Quality and Regulatory Affairs to drive strategic alignment with evolving international standards and regulatory expectations. This role is also responsible for BD SM global external engagement for standards development and shaping ensuring medical device industry perspectives are effectively represented in technical and regulatory guidance. Collaborate across internal and external stakeholders to influence harmonization efforts and promote scientific excellence in the preanalytical phase of laboratory medicine. Ensures BD's representation at different international boards and committees. The ICL Strategic Manager demonstrates understanding of technical/scientific principles applicable to in-vitro diagnostics and those of associated disciplines (such as R&D, Regulatory Affairs, Quality Assurance, or Project Management). This role represents the interest of the patient and the health care worker and understands patient safety and product safety and risk assessment. The ICL Strategic Manager has working knowledge of international regulations and able to translate scientific and technical insights into actionable strategies. Duties and Responsibilities: Owns the Medical Affairs activities for the instrument company liaison initiative and actively driving different activities/projects under this initiative Lead strategy development and execution for the ICL initiative from MA standpoint working jointly with other functions in the core team of ICL Supports in creating and maintaining ICL database on engagements/projects with different instrument companies Serves as an internal cross-functional scientific liaison across BD SM MA, R&D, Marketing, Quality and Regulatory Affairs to drive strategic alignment with evolving international standards and regulatory expectations Responsible for global external engagement for standards development ensuring voicing out the role of medical devices and importance of the preanalytical phase in technical and regulatory guidance Represents BD SM at different international associations, committees and boards Establish communication to represent BD with different accreditation bodies, like CAP, Joint Commission and others Educate cross-functional internal teams on insights for emerging practices, guidance, standards and gaps Collaborate with MA stakeholders on scientific publications resulting from the different external engagement activities Public speaking in forums, conferences and specialized meetings related to medical device industry and collaboration with analytical companies Engage and increase awareness of different instrument companies on preanalytical practices and BD SM solutions Complies with BD policies and procedures while demonstrating awareness of BD products, product development process, international standards and regulations.

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